All medical domains services

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

MRI 3 Tesla (Philips Ingenia Edition X), imaging, data acquisition, clinical

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, MRI Centre, aims to catalyse novel and translational research using MRI. We offer a state-of-the-art 3 Tesla GE SIGNA Premier system-wide bore gantry and high-performance XT gradients. We support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits and module technical support. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facilities, Karolinska Experimental Research and Imaging Centre (KERIC) and the MRI Centre, aim to catalyse novel and translatory research using MRI. At KERIC, we offer a 9.4T MRI for animals such as rabbits and small piglets (see service for small animal 9.4T MRI). A state-of-the-art 3 Tesla GE SIGNA Premier system-wide bore gantry and high-performance XT gradients are available for large animal preclinical studies. We offer specialised services for large animal models as well as ex vivo imaging and support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits, module technical support and animal technicians. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc Or https://imagingresearch.se/facilities/corefacilities/keric

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, MRI Centre, aims to catalyse novel and translational research using MRI. A unique next-generation clinical 7 Tesla Siemens MAGNETOM Terra.X. equipped with an ultra-high field scanner also offers cutting-edge gradient performance (130 mT/m at 250 T/m/s), parallel transmission, as well as deep learning-based acceleration and denoising for improved image quality. Micrometre resolution in vivo for microstructural imaging and layered fMRI. We support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits and module technical support. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility Karolinska Experimental Research and Imaging Centre (KERIC), we have a preclinical 9.4T Bruker USR 94/30 MRI system. The state-of-the-art 9.4T MRI is equipped with single-mouse, single-rat, or double-mouse beds. It has three gradient bore sizes to arrange an effective inner diameter of 20cm (large animals), 12cm (medium animals) or 6cm (small animals). Methods in anatomical imaging, fMRI, Ex vivo, Pharmacological MRI and Cardiac imaging (CINE). For the mouse brain, a 4-channel phased array cry-coil drastically increased signal-to-noise. In this service, we offer full support in project consultation, ethical permits, module technical support, animal technicians and data analysis. We can host animals directly or indirectly through collaboration within KU (AKM) and other animal labs. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/keric

Karolinska Institutet (KI)

The Unit: Chemical Biology Consortium Sweden (https://www.scilifelab.se/units/cbcs/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Chemical Biology Consortium Sweden (CBCS) is a national research infrastructure offering an extensive portfolio of services - from computational and organic chemistry to phenotypic small molecule screens in cells and model organisms, cell painting and functional precision medicine. The mission of CBCS is to provide a state-of-the-art platform and expertise for the generation of high-quality bioactive chemical tools (small organic molecules) for applications within life science research in general and with the ultimate goal to explore complex biology. Our units comprise compound handling labs (hosting the SciLifeLab Compound Collection of ca 350,000 molecules), screening labs (microtiter format liquid handling robotics and a wide range of plate readers), and chemistry labs (equipment and instrumentation for organic chemistry synthesis and analysis). The service: Access to compound collection https://www.cbcs.se/the-compound-collection The Scilifelab Compound Collection is managed by the Compound Center at CBCS KI, and is based on donations of high-quality sets from the pharmaceutical industry (Biovitrum, Karobio, Orexo/Biolipox, KDev) and has been developed and expanded with compounds from various commercial compound vendors. The compounds can be readily available in assay-ready plates through acoustic nano-litre scale liquid dispensing or in 96-tube racks; compounds are stored at 10mM concentration in DMSO solution at - 20 °C under humidity control. We provide: o Management, storage, and processing of solids and liquids. o Compound delivery and interface with key customers. o Performance of instruments and automation that support these operations. o Analytical techniques used for quality assurance. o Sample informatics, including registration and compound quality data.

Politecnico Di Milano (POLIMI)

Providing expertise in the field of medical robotics (medical imaging for surgical planning, virtual reality, extended reality) to be eventually tailored to specific projects: 1) Definition of applications objectives 2) Data collection, data curation and bias evaluation 3) Preprocessing and optimization of feature extractions 4) Selection of suitable machine learning models, model training and testing 5) External validation 6) Interpretations of models (XAI algorithm applications and development) Keywords: AI, algorithm development, AI testing and validation, Medical Imaging for Surgical Planning, Virtual Reality, Extended Reality

Fondazione Bruno Kessler (FBK)

This service covers all key aspects of development and deployment of AI solutions, based on shallow machine learning or deep learning). State-of-the-art pipelines are generated/improved leveraging on various technonolgies or solutions such as: data encoding, management of missing data, data augmentation and syntetic data generation, model selection and optimisation, hyperparameters tuning, fine-tuning, data shift and transfer learning, reproducibility and explainability. Keywords: Biomedical data Analysis, Deep Learning, CNN, Machine Learning, Image Analysis, Synthetic Data Generation

Multitel (MULTITEL)

Design, Optimization and Small Series Production of Prototypes: The MULTITEL team excels in creating bespoke prototypes and limited series, demonstrating the potential of AI and optoelectronics applications in various domains.

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Evaluation of medical AI using real-world Data and Synthetic Data to create a strong technical AI evaluation report. Method: evaluation of medical AI products, taking into account the differences between subpopulations, sources of bias, metric selection, uncertainty intervals, among others. Keywords: AI performance evaluation, test report

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Specialized training on how to thoroughly evaluate the performance of Medical AI models and create test reports for notified bodies. Medthod: Organisation of in-person and online training for Medical AI companies to enable them to create strong technical AI evaluation reports. Keywords: AI performance evaluation, test report, course

Multitel (MULTITEL)

Development and improvement of innovative AI solutions, tailored to the unique challenges and opportunities of the SME. From 1D, 2D, 3D data or multimodal data, MULTITEL develops and improves customized AI models, leveraging its expertise in AI, embedded systems, machine learning, optoelectronics and optics to deliver robust, efficient solutions. With a focus on refinement, MULTITEL also enhances the performance of existing AI models, ensuring they meet the latest standards in speed, accuracy, and functionality.

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

The service offers SMEs expert evaluation and validation of their AI models intended for clinical use. Leveraging the hospital's domain expertise in healthcare and data analytics, this service assesses the accuracy and clinical suitability of AI models in real-world clinical scenarios by assessing models against clinically relevant metrics, benchmarks, and regulatory standards, it ensures their safety, reliability, and effectiveness in real-world healthcare settings.

Centro Hospitalar De Sao Joao Epe (CHSJ)

The service offers SMEs expert evaluation and validation of their AI models intended for clinical use. Leveraging the hospital's domain expertise in healthcare and data analytics, this service assesses the accuracy and clinical suitability of AI models in real-world clinical scenarios by assessing models against clinically relevant metrics, benchmarks, and regulatory standards, it ensures their safety, reliability, and effectiveness in real-world healthcare settings.

Multitel (MULTITEL)

This service provides an independent and reproducible evaluation of AI model performance using well-established quantitative metrics. The evaluation is conducted in a controlled and documented execution environment to ensure traceability and repeatability of results. Performance is assessed on client-provided datasets and models, and associated measurement uncertainties are systematically analyzed and reported. The service delivers a detailed and interpretable evaluation report. All activities are performed under ISO 9001 certified processes.

Zilinska Univerzita V Ziline (UNIZA)

Tailored development and consultation of AI models, including supervised, unsupervised, and reinforcement learning approaches. This service supports SMEs in designing, training, validating, and deploying AI solutions. Technical details:Python-based frameworks (TensorFlow, PyTorch), model hosting options. Use cases/examples:SME is looking for information on how to evaluate their model or how to design adequate architecture.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Helping to rigorous testing and validation of the developed Multimodal AI models in real hospital environments based on real-world medical images and with collaboration with AI experts and medical staff. In collaboration with the medical staff and advanced deep learning algorithms, test the AI models on datasets not yet seen by the AI to confirm the correct behaviour of the AI. Discussion with medical experts and validation with new data sets (continuous learning) to ensure that the AI is still correct even with new data). Verification that there are no biases. Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Vlaamse Instelling Voor Technologisch Onderzoek N.V. (VITO)

Semi-automated performance monitoring of the Medical AI deployed in the clinical practice, following PMS regulation. Making the distinction between deployments where good model performance can be guaranteed and where not. Consultancy services on automated model performance monitoring in the clinical practice, in compliance with Medical Device Regulation (MDR). Keywords: AI performance evaluation, performance monitoring, PMS, PMCF

Laboratoire National De Metrologie Et D'Essais (LNE)

Based on the domain of the medical device or robot provided by the customer, the simulation will create a test environment relevant to the system to be evaluated using a video-projection system. The service will be provided using the LE.IA Immersion platform, a platform dedicated to the evaluation of AI. It consists of a video-projection system that makes it possible to reconstitute an "artificial nature" and to immerse the systems to be characterised (personal assistance robots, intelligent cameras, civil and military intervention robots, etc.) in a simulated dynamic reality. It allows the system (robot, camera, etc.) to be subjected to a multitude of test scenarios and to evaluate its reactions in a controlled environment.

Laboratoire National De Metrologie Et D'Essais (LNE)

To ensure that their solution works accordingly regarding a task, AI provider have to evaluate their system using a specific dataset. The performance obtained on this dataset helps to prove the adequate performance of their AI solution. However, the evaluation process can be often quite hard for an AI provider to do properly: the evaluation dataset needs to be correctly qualified, and the creation of the evaluation protocol as well as the analysis of the results are not easy tasks. This service allows AI provider to benefit of the LNE expertise with a full evaluation of their AI system: using an evaluation dataset created for the test or provided by a partner of the TEF project, an assessment of the performance of the AI system is done, and an analysis of its behavior provided. This work also includes a quality assessment of the evaluation dataset. The scope of the analysis of the evaluation results can include robustness and resilience evaluation, depending of the needs of the SMEs. With this service, the customer will have a full assessment of its solution, allowing them to answer the accuracy requirements of the AI regulation, while also having a full report following all transparency and reproductibility requirements. This service generally takes around 2 months, depending of the needs of the customers.

Laboratoire National De Metrologie Et D'Essais (LNE)

The system provided by the customer, for instance a medical device using an AI module, will be tested using a simulated environment. The service will be provided using the LE.IA Simulation, a fully simulated test environment (the robot or the medical device and its operating environment are simulated). It allows to generate a very large number of test scenarios that are not feasible in a physical environment.

RISE Research Institutes Of Sweden

Your AI models might be leaking personal data or trade secrets. GDPR and the AI Act expect you to check this — not hope for the best. We deliver reproducible and defensible testing, so your decisions — and your audits — rest on evidence instead of assumptions. Organisations that build or deploy AI models must meet strict privacy and cybersecurity obligations under GDPR, the EU AI Act, and sector‑specific rules. Models can unintentionally memorise and leak personal data through attacks such as membership inference, data reconstruction, and data extraction — creating real compliance and reputational risks. GDPR requires organisations to prevent downstream exposure of personal data and to honour the Right to be Forgotten, which in practice demands testing whether individual training data still leaves detectable traces inside a model. Beyond privacy, AI models may also reveal proprietary or confidential business information, turning leakage into an IP and cybersecurity risk, not just a data‑protection issue. The EU AI Act reinforces this by requiring testing under foreseeable misuse, including privacy‑relevant attacks. LeakPro provides structured, empirical stress‑testing of AI models to measure privacy and IP leakage, validate privacy‑enhancing technologies, and generate audit‑ready evidence for DPIAs, GDPR, and AI Act compliance. This service maps to the following articles within AI-act: • Article 9 Risk management system — Continuous lifecycle risk management to keep your AI compliant and under control. • Article 10 Data and Data Governance — Validate that your training data meets state-of-the-art privacy and security standards. • Article 15 Accuracy, robustness and cybersecurity — Proactively detect and mitigate confidentiality attacks before they become real risks. The audit reports constitute evidence that feeds into the technical documentation (Article 11 — Technical documentation, Annex IV). How can the service help you? • Detect leakage of personal data, sensitive attributes, or proprietary information. • Check data traceability to support GDPR Right‑to‑be‑Forgotten obligations. • Validate and tune synthetic data, federated learning, and differential privacy. • Provide quantitative leakage‑risk indicators for audits, DPIAs, and procurement. • Advise on privacy‑resilient AI design already at investment and planning. How the service will be delivered Logistics • Delivered via RISE secure environments or customer infrastructure. • Supports models across text, tabular, image, time‑series and graph modalities. • Option for iterative collaboration during model development or one‑off audits. Delivery period Engagements are planned in phases depending on the scope, starting with a general assessment (qualitative), followed by attack simulation (quantitative) and reporting. Duration • Short engagement: 3–6 weeks • Complex model audits or PET optimization: 2–4 months Customer requirement • Provide intended use-case, regulatory context, and risk appetite • Documentation of model development and system environment. • Optional: Access to model artefacts and training data for technical study. Deliveries • Tailored attack suite configuration • Execution of privacy and IP leakage attacks • PET tuning recommendations • Compliance‑aligned summary (reporting evidence for GDPR, AI Act, etc) Output • Technical leakage‑risk metrics • Training data traceability assessment (Right‑to‑be‑Forgotten) • Harm‑oriented explanation for DPIAs • Recommendations for mitigation and governance

Laboratoire National De Metrologie Et D'Essais (LNE)

AI resilience evaluation: evaluation of an AI system using a test dataset. This dataset will contain erroneous data designed to disturbed the behavior of the AI system. The general methodology will include the design of test protocols, the realization of tests, the analysis of results and production of a test reports.

Laboratoire National De Metrologie Et D'Essais (LNE)

Evaluation of an AI system using a test dataset augmented with artificial data. The new data results in a wide coverage of the operating range and addition of artificial noise based on the nature of the data processed by the AI system. The LNE data augmentation tools can apply physically-informed transformations to visual data and timeseries data. The visual transformations include for instance: gaussian (electrical) and poisson (thermal) noise, gaussian blur (focus issues), loss of pixels, lines and columns (CCD failures). The timeseries transformations include random gaussian, laplace or uniform noises.

Multitel (MULTITEL)

Technology Watch and Guidance: MULTITEL keeps businesses at the forefront of AI advancements, offering insights and guidance in emerging technologies. Technical Tests and Feasibility Studies: MULTITEL rigorously tests and assess the practicality of AI solutions, ensuring they align with your business needs. Keywords: AI technical support

Politecnico Di Milano (POLIMI)

Conceiving, developing and optimization of AI algorithmic approaches across the whole pathway: 1) Definition of applications objectives 2) Data collection, data curation and bias evaluation 3) Preprocessing and optimisation of feature extractions 4) Selection of suitable machine learning models, model training and testing 5) External validation 6) Interpretations of models (XAI algorithm applications and development). Keywords: AI, algorithm development, AI testing and validation, Data Curation, Feature Extraction, Learning Models, External Validation, XAI

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

AI-backed services around algorithm improvement are offered after individual consulting. We provide expertise in algorithm improvement for start-ups/SMEs based on their specific needs https://doi.org/10.1109/OJEMB.2024.3356791 Keywords: Algorithm, AI, data science, medical data, agile development

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Anatomic pathology slides: preparation +/- associated patient clinical data +/- analysis +/- software evaluation +/- medical expertise; cancer, lesion, sample, biopsy, tissue, organ; histology, diagnosis, genetic; microscope, scanner

Karolinska Institutet (KI)

The Unit: Chemical Biology Consortium Sweden (https://www.scilifelab.se/units/cbcs/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Chemical Biology Consortium Sweden (CBCS) is a national research infrastructure offering an extensive portfolio of services - from computational and organic chemistry to phenotypic small molecule screens in cells and model organisms, cell painting and functional precision medicine. The mission of CBCS is to provide a state-of-the-art platform and expertise for the generation of high-quality bioactive chemical tools (small organic molecules) for applications within life science research in general and with the ultimate goal to explore complex biology. Our units comprise compound handling labs (hosting the SciLifeLab Compound Collection of ca 350,000 molecules), screening labs (microtiter format liquid handling robotics and a wide range of plate readers), and chemistry labs (equipment and instrumentation for organic chemistry synthesis and analysis). The service: Assay development & highthroughput screening We provide expertise and technical support in the following areas: o Access to small-molecule compound libraries and robotic instrumentation. o Expertise in assay development and automation. o High-throughput screening: biochemical target-based, cell-based and phenotypic. o High-throughput imaging technology. o Computational chemistry and modelling. o Medicinal chemistry expertise. o Chemical Biology Platform. Perspective use case: Purpose The Cell Painting technology can be used to visualize many cellular parameters simultaneously, using organelle-specific fluorescent dyes and high-content imaging. This approach allows you to systematically visualize how cell morphologies react to certain stimuli, like chemical perturbations. It is thus possible to foresee in the near future that the CP technology is a valuable technology to create large systematic AI minable cell morphology resources and customized validation data sets for profiling small molecules and other treatment modalities. Development of new AI software for morphology profiling, cell segmentation for validation sets for functional perturbation assays are needed for future precision medicine. Description of service/ technology: Cell painting, high-content imaging, high-throughput screening Drug library design and delivery, cell culture and immunofluorescence staining Dataset generation, data analysis AI software development Expected outcome: New dataset generation to train AI algorithm on the different type of images generated. Improvement of AI algorithm.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Logistic & Process Optimisation: Provide expertise on how to address large scale logistic, scheduling, and other combinatorial optimisation problems using constraint-based local search. CETIC has developed a routing optimization algorithm called RoutaR. It is based on the oscar.cbls optimization engine and on GraphHopper cartography. Both are open source. Method Description: It inputs a routing problem, expressed in a Json file format. It typically contains a set of geographic locations, a description of a fleet of vehicles and a set of constraints. It produces a routing solution; a planning of each vehicle of the considered fleet that mentions their tasks and geographic locations Method reference: https://www.cetic.be/RoutaR-outil-de-planification-performant-et-facilement-adaptable

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Kit preparation; reception of sample +/- inventry +/-relabelling +/- entry of additional medical data +/- managing of consents; aliquoting; ficoll; cell count viability; extraction (RNA, DNA); freezing and conservation (-150°C, -80°C, -20°C, +4°C, nitrogen); cell culture and maintenance; preparation of parafin from fresh or frozen tissues; biobank, biological sample, aliquot, storage, tissue, cell, blood, urine

Univerzita Komenskeho V Bratislave (UK BA)

The laboratory performs research and scientific activities in the research of autonomic nervous system regulation. It uses Finometer (FMS) and Nexfin (Edwards Lifesciences) devices, which are used for non-invasive beat-to-beat blood pressure monitoring using volume-clamp method, and MedGem (Microlife) for determination of basal metabolism. It uses ECG Cardiofax 9620M (Nihon Cohden) for monitoring the electrical activity of the heart, RespiTrace (NIMS) for non-invasive respiratory monitoring by impedance method using chest and abdominal belts, CardioScreen 2000 (Medis) for non-invasive monitoring of various parameters associated with pumping function of the heart (systolic volume, systolic time intervals, etc.). It uses VaSera VS-1500N (Fukuda Denshi) characterization of arterial stiffness, EndoPAT 2000 (Itamar Medical) - characterization of endothelial dysfunction, InBody J10 (Biospace) - analysis of body composition, ECG (BTL; Pola V8) - non-invasive continuous bio signals monitoring, Finometer (Finapres medical systems), blood pressure, Flex Comp Infinity, Thought Technology for measuring the electrodermal activity, respiration, peripheral temperature, Neuroptics PLR200, pupilometry, Eyetracking (Pupil Labs) for eye movements, InBody 120 - body composition analysis.

Politecnico Di Milano (POLIMI)

This service offers biostatistical consulting relevant to Data Analysis to be obtained through the clinical evaluation procedure and relevant statistical evaluation; Application of MDCG 2020-1 principles in the design of the specific clinical study. Keywords: Clinical investigation, clinical study, clinical evaluation procedure, statistical analysis;

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

Consulting support related to all aspects of business model development. Keywords: Business Analysis, business plan, market

Univerzita Komenskeho V Bratislave (UK BA)

Expertise in vitro cultivation various types of cells (human and animal), molecular analysis, imaging protocols and analysis, study design, full service measurement, academic applications. Cell culture laboratory equipment includes BSL-2 flow boxes, CO2 incubators, light microscope, cell counter; molecular laboratory equipment (RT-PCR thermocyclers, agarose/SDS-PAGE apparatus and Western blot transfers, Elisa plate reader), cellular analysis (cellular processes analyzer, fluorescent microscopy scanner.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Clinical Researchers and Investigators: For gaining insights into the feasibility of proposed studies and enhancing study designs with practical clinical input. - Healthcare Institutions: To expand research capabilities by connecting with technical and clinical experts and facilities. - Research and Development Teams: For testing new technologies or methodologies in applicable clinical contexts, ensuring innovative solutions are viable and effective. **Key Features:** - Technical Feasibility Assessment: Organizes and conducts comprehensive technical feasibility studies to evaluate the practicality and potential of clinical research projects. - Connection to Clinical Personnel: Facilitates collaboration between researchers and clinical experts at University Clinic Erlangen, ensuring access to expertise and resources necessary for study success. - Access to Real-Life and Laboratory Test Environments: Provides opportunities to conduct studies within associated clinics, leveraging previous experience in cardiology, neurology, and biomechanics to ensure practical and applicable results. **Possible Applications:** - Project Feasibility Evaluation: Assists in determining the feasibility of clinical research projects, helping to identify potential challenges and solutions early in the development phase. - Research Collaboration: Enhances research outcomes through the integration of clinical expertise and real-world testing environments, ensuring studies are rooted in clinical reality. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Hospices Civils De Lyon (HCL)

Submission to the French regulatory authorities (Ethical committee CPP, ANSM). Feedback management with these regulatory authorities to take into account their requirements.

Hospices Civils De Lyon (HCL)

Journals, Meetings, Events

Hospices Civils De Lyon (HCL)

Definition of the company needs and suggestions. Identification/access to expert medical opinion. Identifying the necessary cross-discipline professionals (inner partners and external providers) Definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...) Budget proposal for the clinical investigation. Support to funding research.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Support SME to define the clinical investigation methodology (number of subjects, study design, endpoints definition, among others) and to write a first synopsis. It may include: - Access to expert medical opinion. - Budget proposal for the clinical investigation. - Support to funding research; Keywords: Clinical investigation, clinical study;

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Support SME to define the clinical investigation methodology (number of subjects, study design, endpoints definition, among others) and to write a first synopsis. It may include: Identification & access to medical & other experts advice; Support to get funding research. Keywords: Clinical investigation, clinical study, methodology, synopsis, funding

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Statistical analysis plan; database consistency check; database freezing; statistical analysis (intermediate and final); writing the final statistical report.

HUMANI SC - Hospital network (HUMANI)

Comprehensive biostatistics services led by a physician biostatistician, including calculation of sample size, power calculation, data randomisation and/or analysis, to support the data-driven assessment of AI solutions maturity. This service is tailored to support the design and production of Clinical Investigation Plans (CIP) and/or Reports (CIR), Case Report Forms (CRF), as well as structured pilot reports documenting the progress of AI solutions from Technology Readiness Level (TRL) 7 to 9.

HUMANI SC - Hospital network (HUMANI)

Assembling the required team of cross-discipline professionals to discuss the feasibility of the project.

HUMANI SC - Hospital network (HUMANI)

Performing all monitoring activities ensuring compliance to the clinical investigation plan and regulatory requirements: site qualification/selection visit, site initiation visit, site monitoring visits, site close-out visit, site audit/inspection support. HUmani can provide this service "à la carte" or with full sponsor role.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Clinical sponsoring/monitoring/vigilance; performing all sponsoring/monitoring/vigilance activities ensuring compliance to the clinical investigation plan and regulatory requirements.

HUMANI SC - Hospital network (HUMANI)

Confidential and Non Disclosure Agreement (CNDA) signature. Listening to clinical research needs. Analyzing the international/national legal and ethical framework (laws, regulations, and ethical principles in force). Liaison with Competent Authorities (CA), experts, key-opinion leaders (KOLs), etc. (where needed). Identifying the necessary cross-discipline professionals (inner partners and external providers or vendors). Proposing comprehensive and customized solutions to optimize SMEs clinical research proposals.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Clinical investigation set-up with patient inclusion, patient follow-up, data collection, queries management, ...; clinical investigation coordination (mono-centric or multi-centric); the hospital may be the sponsor or an associated investigation center.

HUMANI SC - Hospital network (HUMANI)

Creating and writing of investigation procedures (study procedures, standard operating procedures, monitoring plans, etc.). HUmani can provide this service "à la carte" or with full sponsor role.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Case Report Form (CRF or e-CRF).

HUMANI SC - Hospital network (HUMANI)

Protocol development/review support. Electronic Case Report Form (CRF) design and production. Paper-CRF design and printing. Database design and set-up. CRF completion guidelines. HUmani can provide this service "à la carte" or with full sponsor role.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Writing the documentation dedicated to the clinical investigation and needed for the regulatory submission: protocol, patient information letter; support to the technical file writing (including the investigator brochure) under the manufacturer responsability.

HUMANI SC - Hospital network (HUMANI)

Creation and provision of essential documents required for clinical investigation implementation and performance: investigation protocol, synopis, Informed Consent Form, investigation agreement, logs, etc. Implementation of clinical investigation files : site master file, investigation sponsor files, etc. HUmani can provide this service "à la carte" or with full sponsor role.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Clinical investigation: Methodology and synopsis; definition of the company needs and suggestions; identification/access to expert medical opinion; identifying the necessary cross-discipline professionals (inner partners and external providers); definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...); budget proposal for the clinical investigation; support to funding research.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Submission to the French regulatory authorities (Ethical committee CPP, ANSM, CNIL); feedback management with these regulatory authorities to take into account their requirements.

HUMANI SC - Hospital network (HUMANI)

Assisting in regulatory submissions in compliance with applicable laws and requirements. Providing with the necessary regulatory documents. Performing regulatory submissions. Liaison with regulatory bodies: Ethics Committees (EC), Federal Agency for Medicines and Health Products (FAMHP), European Medicines Agency (EMA). HUmani can provide this service "à la carte" or with full sponsor role.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Scientific communication/dissemination: journals, reviews, meetings, events.

HUMANI SC - Hospital network (HUMANI)

Technical feasibility study for the implementation of medical devices in acute care areas, such as operating theatres, intensive care units, etc. Support for interfacing sensors and medical devices to a data warehouse. Carry out maintenance and monitoring activities to ensure the connectivity of the device to be tested with the infrastructure and the transmission of data. Support in implementing the solution. Daily technical support for care unit beta-testers. Technical evaluation report on the solution (functionality, ergonomics, durability, etc). HUmani can provide this service "à la carte" or with full sponsor role.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Statistical Analysis Plan. Database consistency check. Database freezing Statistical analysis (intermediraire et final) Writing the final statistical report

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Clinical investigation set-up of the with patient inclusion, patient follow-up, data collection, queries management, ... • Clinical investigation coordination (mono-centric or multi-centric). • The IHU may be the sponsor or an associated investigation center.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Submission to the French regulatory authorities (Ethical committee CPP, ANSM). • Feedback management with these regulatory authorities to take into account their requirements.

Hospices Civils De Lyon (HCL)

Clinical sponsoring/monitoring/vigilance. Performing all sponsoring/monitoring/vigilance activities ensuring compliance to the clinical investigation plan and regulatory requirements.

Hospices Civils De Lyon (HCL)

Clinical investigation set-up with patient inclusion, patient follow-up, data collection, queries management, ... Clinical investigation coordination (mono-centric or multi-centric). The hospital may be the sponsor or an associated investigation center

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Clinical sponsoring/monitoring/vigilance. Performing all sponsoring/monitoring/vigilance activities ensuring compliance to the clinical investigation plan and regulatory requirements

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Clinical investigation set-up of the with patient inclusion, patient follow-up, data collection, queries management, ... Clinical investigation coordination (mono-centric or multi-centric). The hospital may be the sponsor or an associated investigation center

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Case Report Form (CRF or e-CRF)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

eCRF, DMP, DVP

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Discussion of the SME needs and suggestions. • Technical feasibility according the medical device maturity

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Writing the documentation dedicated to the clinical investigation and needed for the regulatory submission: protocol, patient information letter. Support to the technical file writing (including the investigator brochure) under the manufacturer responsability.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Writing the documentation dedicated to the clinical investigation and needed for the regulatory submission: protocol, patient information letter. Support to the technical file writing (including the investigator brochure) under the manufacturer responsability.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Clinical investigation-Methodology and synopsis Prerequisite: the medical device maturity has been defined Definition of the company needs and suggestions. Identification/access to expert medical opinion. Identifying the necessary cross-discipline professionals (inner partners and external providers) Definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...) Budget proposal for the clinical investigation. Support to funding research.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Definition of the SME needs and suggestions. • Access to expert medical opinion. • Definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...) • Budget proposal for the clinical investigation. Support to funding research

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Assisting SMEs in regulatory submissions in compliance with applicable laws and requirements • Providing SMEs with the necessary regulatory documents • Liaison with regulatory bodies: Ethics Committees (EC), National Agency of Drugs Safety (ANSM)

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Submission to the French regulatory authorities (Ethical committee: CPP, ANSM). Feedback management with these regulatory authorities to take into account their requirements.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Scientific communication/dissemination: Journals; Meetings; Events.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Journals, Meetings, Events

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service includes first meetings with experts in clinical investigation to help the SME in the maturation process of its innovative medical device and define the main steps in the clinical study process depending the SME needs. Definition of the SME needs; Confirmation of the product maturity level; Identification & access to medical & other experts advice, inner partners & external providers; Support to estimate funding research. Keywords: Clinical investigation, clinical study, feasibility, expertise, maturity, TRL

Centre Hospitalier Universitaire De Grenoble (CHUGA)

This service includes first meetings with experts in clinical investigation to support the SME in the maturation process of its innovative medical device and define the main steps in the clinical study process depending the SME needs. Access to expert medical opinion. Support to funding research; Keywords: Clinical investigation, clinical study;

Politecnico Di Milano (POLIMI)

Consulting on the design of a clinical protocol for the clinical evaluation procedure to collect clinical data in support to the certification process throughout the lifecycle of the medical device. Application of MDCG 2020-1 principles in the design of the specif clinical study; MDCG 2020-1. Keywords: Clinical investigation, clinical study, clinical evaluation procedure, CE certification process

Istituto Giannina Gaslini (IGG)

Consulting for designing Clinical Trials in a realistic pediatric environment. Keywords: Ethical commettee documentation; Pediatric environment; Clinical trial roadmap; Statistics; best trial type determination;

Politecnico Di Milano (POLIMI)

Comparative study of competing products in the market of rehabilitation robotics. Support testing protocol design with healthy, elderly and post-stroke subjects and comparison with benchmarking. For Upper Limb robotics see paper DOI 10.1186/s12984-022-01082-8. Keywords: Comparative study, Market Analysis, Healthcare Robotics, Upper Limb

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

Benchmarking analysis reports to help SMEs assess their position in relation to global competitors. Keywords: Competitors; Market; Business

Multitel (MULTITEL)

EMC Testing for product development and pre-certification for conducted emission and immunity tests. This service will be deliver in the Multitel anechoïc chamber located in Mons (Belgium). The device under test could reach 1,5 m diameter and 1 ton weight. The main standard that could be tested are relevant for electronic devices, medical devices, aeronautic devices, ... : CISPR 11/ EN55011, CISPR32/EN 55032, EN 61000-4-3, EN 60601

Laboratoire National De Metrologie Et D'Essais (LNE)

Study and assess the development and evaluation process used by the SME/startup in the development of an AI system. The service consists of an assessment of the development process and evaluation of the AI systems. The consulting service method is based on the study of the documentation describing the process and meetings with the AI team. Keywords: Process assessment, process improvement, data qualification, documentation, transparency, tracability, evaluation

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Through the established network with hospitals across Europe. In coordination with each hospital, IPN has Clinical Investigation Coordinators fully dedicated to managing clinical research. In this service, IPN identifies the requirements for testing and experimentation of the solution, presents the solution and the testing needs to partner hospitals that meet the requirements, and defines Clinical Research Teams and the Principal Investigator for future studies.

Zilinska Univerzita V Ziline (UNIZA)

Development of intelligent, conversational chatbots powered by large language models (LLMs), tailored to specific healthcare, research, or business needs. These chatbots can understand and generate natural language responses, integrate with organizational knowledge bases, and support advanced tasks such as appointment scheduling, information retrieval, or interactive education. Technical details:Python, LLMs, custom datasets. Use cases/examples: SME wants to develop a chatbot service that would help users operate with their AI system.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Providing prebuilt AI pipelines tailored for medical image analysis. Streamlining AI model integration into existing healthcare workflows. Accelerating the deployment of AI solutions in clinical settings. Using MLOps and DVC to accelerate the AI development and deployment with CI-CD pipelines. Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Cyber-Physical Systems Cybersecurity Testing ensures cyber-physical systems (CPS), such as robotic systems, comply with security requirements and standards (such as Cyber Resilience Act). Security testing includes security functional testing of the whole system, and vulnerability scanning of the software components. The overall goal is to release your product without known important vulnerabilities. How can the service help you? Our service is based on a custom platform that automates vulnerability scanning, penetration testing and security functional testing, with the possibility to integrate our platform in your DevSecOps activities for full security activities automation. The focus on cyber-physical systems takes the form of support for physical interfaces and buses/protocols, with possible attacks on RF signals (GPS or WiFi), for example. Our offer differentiates from existing ones with a unique risk-based approach, where a security risk analysis drives the whole process of security testing, and by the use of open-source tools to avoid vendor lock-in. The method is based on existing standards : PTES, Etsi, NIST, FDAM... How the service will be delivered? Based on information provided by the customer about their system, this service offers to use our Automated Cybersecurity Testing platform, tools and method to define and perform cybersecurity tests, either on site or in our lab. Optionally, we can integrate our platform in your DevSecOps chain for full automation of security activities. Optionally, we can perform the security risk analysis that is used as input for the whole process. We will provide complete test reports as well as recommendations to lower the residual risk level and attack surface of your system. Together with the risk analysis, they can be used as a complete set of evidences towards authorities and customers. Service deployment: The service is deployed either on site or in our lab. Our test platform is made of several components : a server that stores all relevant information and generate the reports, and test workstations that can be used in our lab or at customer sites directly. Service standards: PTES, Etsi, NIST, FDAM...

Karolinska Institutet (KI)

## Overview This service provides a complete organisation or re-organisation of your datasets as well as guidance in selecting the most appropriate metadata management methodology. We offer data cleaning (e.g., renaming, annotation, formatting, and duplicate removal), quality control, and anonymization tailored to SME needs. This service aims to provide assistance based on a dataset management plan. We follow community data and metadata standards in place and offer curated, up-to-date guidance based on FAIR principles (Findable, Accessible, Interoperable and Reusable) whenever possible. We have expertise in data and metadata standards in many life science fields, including, more specifically, imaging (PET, MRI, MEG, EEG) and structural data, genomics, metabolomics, and proteomics data. Expertise in legal and ethical aspects of dataset management can also be provided. We provide expertise and technical support in the following areas: - Project design & management - Legal & ethical support - Data cleaning, annotation, anonymisation ### How can the service help you? This service helps SMEs improve the organization and usability of their datasets by providing data cleaning, quality control, and anonymization tailored to their needs. With expert guidance on metadata management and adherence to FAIR principles, it ensures your data is reliable, compliant, and ready for effective use, building trust and confidence in your data-driven initiatives. ### How the service will be delivered? The service will be delivered according to established ethical agreements and guidelines, in collaboration with the SME and researchers from the Swedish TEF-Health node. Data processing is facilitated through a secure virtual environment managed by Karolinska Institutet, ensuring the highest standards of data protection. --- ## Additional information ### Provider description The Swedish TEF-Health node is a collaboration between Karolinska Institutet, SciLifeLab and RISE, and is led by Karolinska Institutet. Together, we offer world-leading services with our unique collection of core facilities. We can grant services in expert consulting, virtual- and physical testing in the range of in vivo imaging, ex vivo OMICS, pharmaceutical development, simulated healthcare environments, AI-system validation and development, advanced data analysis and other data-driven life science. ### Technical description The service restructures and processes datasets within a secure computing environment utilizing advanced data curation and metadata management frameworks. Data preprocessing operations, including nomenclature standardization, semantic annotation and format normalization are executed in compliance with domain-specific ontologies and if possible FAIR principles. Quality assurance protocols are implemented to validate data integrity and compliance. Metadata schemas are optimized for interoperability and reuse, leveraging established standards such as RDF and JSON-LD. ### Service customization The service can be customized according to your specific needs. It may be required to combine this service with other services on offer. --- ## Use case example ### Context A life science SME specializing in metabolomics has developed a novel pipeline for identifying biomarkers in rare metabolic disorders. They have generated extensive LC-MS/MS datasets from patient samples across multiple studies. However, the datasets are stored in a mix of proprietary formats, lack harmonized metadata and do not meet the submission requirements of repositories like MetaboLights. This situation delays the publication of their findings, limiting their visibility and ability to secure collaborations or funding for further pipeline validation. ### Objective To clean, harmonize and annotate the SME’s LC-MS/MS datasets according to MetaboLights requirements. Ensure compliance with FAIR principles to facilitate immediate repository submission and support future scalability. ### Solution The SME engages with the Swedish TEF-Health node to reorganize and optimize their metabolomics datasets for repository submission. Experts provide tailored data cleaning, format conversion, and metadata harmonization, ensuring compatibility with repository standards and enabling wider reuse of the data. ### Implementation #### Ethical Agreement The SME enters into an ethical agreement with researchers from the Swedish TEF-Health node, ensuring all data collection and usage complies with GDPR and national Swedish regulations. #### Secure Access Usage of the collected data is facilitated through a secure virtual environment managed by Karolinska Institutet, ensuring the highest standards of data protection. #### Data Processing and Format Conversion The SME’s raw datasets, stored in various proprietary formats, are converted into open formats such as mzML and mzTab, which are compatible with repository requirements. During this process, quality control measures, including noise filtering and peak annotation, are applied to improve data integrity and reliability. #### Metadata Harmonization Metadata schemas based on MetaboLights standards are created. These schemas incorporate essential details about study design, sample preparation and instrument parameters. Ontology based annotation is applied to harmonize metadata across all datasets, ensuring consistency and compliance with repository guidelines. ### Benefits - **FAIR Data Management**: Enhances SMEs’ ability to manage and share clinical trial data effectively while ensuring interoperability and quality. - **Stakeholder Credibility**: A well-structured data management plan builds trust with regulators, funders, and collaborators. - **Regulatory Compliance**: Ensures adherence to ethical and legal standards, reducing data handling risks. - **Data Sustainability**: Supports long-term usability and scalability, enabling future research opportunities. ### Impact The SME’s biomarker discovery pipeline gains recognition as a reliable and validated tool in the rare disease research community. Their repository-submitted data fosters new collaborations with academic researchers and industry stakeholders, accelerating the translation of their findings into clinical applications.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Consolidate a (multicentric) medical database including medical imaging and patient records. Assess the quality control of the medical database regarding data and GDPR requirements; Classification and categorization of the data regarding medical biases Keywords: Data, AI, regulatory, preclinical and clinical testing, surgery

Karolinska Institutet (KI)

## Overview This service empowers projects to efficiently plan and manage their data through a structured system and expert support. The system is built on the Data Stewardship Wizard (DSW), a tool developed by ELIXIR, a European life science intergovernmental organization, and operated by the SciLifeLab Data Centre. Expert data stewards provide personalized guidance, leveraging best practices and resources from the ELIXIR RDMkit and SciLifeLab’s data guidelines. We provide expertise and technical support in the following areas: - A comprehensive data management planning system with ready-to-use templates. - Expert advice and assistance in data stewardship and management, tailored to your project’s needs. This service ensures that your data management plan aligns with FAIR principles and established standards, promoting high-quality data practices and enabling better long-term data usability. ### How can the service help you? This service helps SMEs and research projects streamline their data management planning by providing access to a robust, user-friendly system and expert guidance. With tailored templates and best-practice guidelines, it ensures that your data management plan complies with established standards. By addressing critical aspects of data stewardship early in the project lifecycle, the service improves data quality, facilitates compliance, and enables better collaboration and long-term reuse of data, ensuring your project’s data is FAIR (Findable, Accessible, Interoperable, and Reusable). ### How the service will be delivered? The service will be delivered according to established ethical agreements and guidelines, in collaboration with the SME and researchers from the Swedish TEF-Health node. --- ## Additional information ### Provider description The Swedish TEF-Health node is a collaboration between Karolinska Institutet, SciLifeLab and RISE, and is led by Karolinska Institutet. Together, we offer world-leading services with our unique collection of core facilities. We can grant services in expert consulting, virtual- and physical testing in the range of in vivo imaging, ex vivo OMICS, pharmaceutical development, simulated healthcare environments, AI-system validation and development, advanced data analysis and other data-driven life science. ### Technical description The service employs the DSW platform to create structured, FAIR-compliant data management plans. It provides customizable templates, enabling collaborative workflows for stakeholders. Expert guidance ensures plans meet domain-specific standards promoting data interoperability and long-term usability. ### Service customization The service can be customized according to your specific needs. --- ## Use case example ### Context A research-focused SME is preparing to launch a multi-center clinical trial for a new biomarker discovery project. The trial will generate extensive genomic, proteomic, and clinical datasets across multiple sites. However, the SME lacks a clear and structured approach to plan how the data will be managed, shared, and stored. Without a robust data management plan, they risk non-compliance with regulatory requirements, inefficient data handling, and challenges in ensuring data interoperability and long-term usability. ### Objective To develop a comprehensive data management plan tailored to the SME’s clinical trial needs, using the DSW platform. Ensure the plan addresses data collection, storage, sharing, and long-term preservation while aligning with FAIR principles and regulatory requirements. Deliver a finalized plan that supports seamless collaboration across trial sites, enhances data quality, and ensures compliance with international standards for research data management. ### Solution The SME collaborates with the Swedish TEF-Health node to create a robust data management plan using the DSW platform. Expert data stewards guide the SME in utilizing customizable templates. The plan is developed collaboratively, addressing key areas such as data collection, metadata standards, storage solutions, and sharing protocols. Regulatory and ethical considerations, including GDPR compliance, are also incorporated. The finalized data management plan is reviewed and optimized to facilitate smooth implementation across all trial sites, ensuring scalability and long-term usability of the data. ### Implementation #### Ethical Agreement The SME enters into an ethical agreement with researchers from the Swedish TEF-Health node, ensuring that all data handling comply with GDPR and Swedish national regulations. #### Data Management Planning Using the DSW platform, the SME collaborates with data stewards to develop a detailed data management plan. The plan incorporates customized templates addressing key elements. #### Review and Optimization The draft data management plan is reviewed collaboratively with stakeholders, ensuring it meets the specific requirements of the clinical trial and complies with all regulatory standards. ### Benefits - **FAIR Data Management**: Enhances SMEs’ ability to manage and share clinical trial data effectively while ensuring interoperability and quality. - **Stakeholder Credibility**: A well-structured data management plan builds trust with regulators, funders, and collaborators. - **Regulatory Compliance**: Ensures adherence to ethical and legal standards, reducing data handling risks. - **Data Sustainability**: Supports long-term usability and scalability, enabling future research opportunities. ### Impact By ensuring high-quality, interoperable data, the SME builds trust with regulatory bodies, funding agencies, and research collaborators. This structured approach to data management fosters new collaborations, accelerates research outcomes, and positions the SME as a leader in clinical trial data handling. The long-term usability of their data enables broader scientific impact, enhancing their reputation and paving the way for future innovations.

Fondazione Bruno Kessler (FBK)

This service covers all aspects regarding the analysis of data useful to understand the task, including problem identification, data curation and preprocessing, statistical and exploratory data analysis, interpretation and visualization. Keywords: Biomedical data Analysis, Data Processing, Data Science.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Consolidate database through curation and data analysing. Keywords: Data, AI, preclinical and clinical testing, surgery

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service aims to formalise and consolidate the SME's request (thanks to our expertise in clinical data warehouse and clinical investigation) and to specify services that we provide which will allow to conduct the study. Eventually, complementary services provided by other partners can be identified. This service includes a consultation session of approximately 2 hours to discuss the proposed project, its key aspects, its direction, and its feasibility. We will leverage our expertise in the reuse of real-world health data, addressing aspects such as data availability, feasibility, regulatory processes, and study methodologies.​ Method Description: The service includes : - Contact form - Documentation of the requirement - Specification document - Identification of the Medical Service Rendered - Identification of inclusion factors, epidemiological factors, factors linked to objectives, confounding factors - Scope : CDWH/CDWH network/SNDS/ academic labs or other TEF partners - Choice/identification of the project manager/sponsor Method reference: Local method respecting General Data Protection Regulation (GDPR), EU regulations 2017/745 and 2020/561 on medical devices, AI Act and Good Clinical Practice (GCP)

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service allows the validation of the clinical question and the feasibility of the SME's request. To be more specific, it first includes a validation of the clinical question with a clinical expert. Then, a pre-screening is conducted to assess data availability, leveraging the expertise of our data scientists, which leads to the production of a feasibility report. Prerequisite: our service "SME initial consulting" must have been previously conducted.​ Method Description: The service includes : - Pre-screening [mandatory] - Feasibility study [mandatory] Method reference: Local method respecting General Data Protection Regulation (GDPR), AI Act and Good Clinical Practice (GCP)

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This support service offer to companies scientific and methodological advice throughout the project. It includes regular progress meetings and ongoing support from a project manager. This may also include support in drafting the research plan and contacts with healthcare professionals. This service provides comprehensive support for companies' R&D projects, with personalized follow-up tailored to their needs, while ensuring the clinical validity of their approaches to exploit clinical warehouse data.​ Details :​ - Meeting with a Clinical Research Project Manager from the Clinical Data Center. The project manager will ensure project management in our institution and key steps related to clinical data warehouse exploitation (e.g., submission to local ethics and scientific commitee).​ - Regular meetings including a group of experts specialized in medicine, clinical data science, clinical research and health technology. Pricing will depend on the mobilized expertise and regularity of the meetings.​ - The opportunity to have your research protocol reviewed and evaluated by experts. This service includes one submission. New submission will result in a re-evaluation of the service charges.​ Prerequisite : our service "Feasibilty study" must have been previously conducted.​ Method Description: The service includes a minimal mandatory task set. Optional tasks can be jointly selected depending on the SME needs and available resources: - Regular progress meetings (fortnightly/monthly) [mandatory] - Review and advice on research plan writing, testing and evaluation [optional] - Review and analysis of research plan by clinicians [optional] Method reference: Local method respecting General Data Protection Regulation (GDPR), EU regulations 2017/745 and 2020/561 on medical devices, AI Act and Good Clinical Practice (GCP)

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service focuses on providing support in analyzing the legal and ethical framework, which involves helping to understand the laws and regulations in force, as well as the ethical principles and values applicable for clinical data warehouse exploitation. It may involve compliance assessment, particularly with regard to RNIPH and legal compliance, which consists in ensuring that the activities in question comply with the applicable laws and rules. It may include assistance with the construction and filing of regulatory dossiers (CEREES, CNIL, etc.). It offers the opportunity to have several documents reviewed and evaluated by experts as some help for CESREES and CNIL submission. This service is tailored by the SME needs.​ Details:​ - An initial consultation meeting with a legal expert of the hospital to clarify the requirements for the CESREES and CNIL submissions.​ - One feedback session and an annotated report for each document (study protocol, data protection impact assessment GDPR, etc.) that the SME needs to revise are included. New submission will result in a re-evaluation of the service charges. Prerequisite : our service "Feasibility study" must have been previously conducted. Method Description: Depending on the SME needs and available resources, this service may include all or part of the following task list: - Analysis of legal and ethical framework (Ethical committee) [optional] - Compliance assessment (RNIPH, legal compliance, etc.) [optional] - Assistance and advice on building regulatory files (CESREES, CNIL, MR004) [optional] Method reference: Local method respecting General Data Protection Regulation (GDPR), Comité d’Expertise pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé (CEREES), Commission Nationale de l’Informatique et des Libertés (CNIL), MR-004 reference methodology requirements and EU regulations 2017/745 and 2020/561 on medical devices

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service provides access to health data from Clinical Data Warehouses of CHU Rennes or/and CHU Grenoble-Alpes and from other clinical data warehouse networks. It includes datamart building (cohort and document selection, mapping to standard...) and data qualification (extraction of clinical variables, data cleaning, clinical consistency checking...) steps. In this way, the service offers companies an opportunity to access healthcare data and/or descriptive statistical analyses.​ This service involves only structured data extraction and pre-processing. In cases where the data is unstructured (e.g., requiring natural language processing for text, feature extraction from images, etc.), a specialized algorithm development service will be required (see our service "Algorithm development" for more details).​ Prerequisite : To have data access, it is essential to have CNIL (Commission Nationale de l'Informatique et des Libertés) approval, a favorable opinion from the Scientific and Ethics Council (CSE), and a signed contract between SME and hospital. Furthermore, our services "Feasibility study" and "Methodological advising" must have been previously conducted.​ Method Description: The service includes a minimal mandatory task set. Optional tasks can be jointly selected depending on the SME needs and available resources: - Datamart building - Patient selection (cohort) [mandatory] - Selection of data of interest [mandatory] - Mapping to FHIR/OMOP standards [optional] - Data qualification steps - Extraction of variables of interest [optional] - Data cleaning [mandatory] - Clinical consistency check by expert [mandatory] - Annotation/segmentation [optional] - Descriptive statistical study [optional] - Confidentiality control [mandatory] - Matching with other databases (i.e., SNDS) [optional] - Deployment of methods on another warehouse [optional] - Datamart availability on Hospital platform (CHU platform) [Standard offer] Method reference: Based on a scientific reference or a method designed by CHU Rennes and its partners (LTSI, LaTIM, etc.), as well as on methodologies provided by WP6. Provision by respecting General Data Protection Regulation (GDPR), AI Act, Good Clinical Practice (GCP) and french legal framework

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service tends to offer a scalable platform to access dataset by the SME taking into account its infrastructure requirements and french legal framework.​ Prerequisite : The dataset must exclusively originate from our data warehouse. Method Description: Depending on the SME needs and available resources, this service may include all or part of the following task list: - Deployment of the dataset on an environment outside CDW Method reference: Provision by respecting General Data Protection Regulation (GDPR), AI Act, Good Clinical Practice (GCP) and french legal framework

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

This service offers method development for tasks at different processing levels (pre-processing, feature extraction, statistical, machine learning and/or deep learning algorithms). In short, it offers support for the full exploitation of data at all processing stages. With this service, companies can benefit from clinical and data science expertise to facilitate the entire healthcare data processing process, including raw data cleaning, extraction of relevant features, statistical analysis and implementation of advanced algorithms. Specific capabilities include text processing using regular expression (regex) filtering or NLP techniques, feature extraction from images, physiological signal through both Machine Learning and Deep Learning algorithms.​ Prerequisite : The dataset must exclusively originate from our data warehouse. Our service "Data provision and analysis" must simultaneously be conducted. Method Description: The service includes: - Drafting of functional specifications [mandatory] - Development of data exploitation methods [mandatory] Method reference: Based on scientific reference or methods designed by CHU Rennes and its partners (LTSI, LaTIM, etc.), as well as on methodologies provided by WP6. Implemented methods will integrate General Data Protection Regulation (GDPR), AI Act, Good Clinical Practice (GCP) insights.

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

The role of this service is to support the promotion and exploitation of research undertaken from an academic point of view. In particular, this involves proofreading and writing scientific articles, as well as participating in scientific conferences. The scientific commercialization service is therefore essential to ensure the dissemination and visibility of research results.​ Prerequisite: The study must have been conducted throught our other services. Method Description: Depending on the SME needs and available resources, this service may include all or part of the following task list: - Scientific article writing [optional] - Proofreading and advice on writing scientific articles [optional] - Participation in scientific events (conferences, etc...) [optional] Method reference: Based on scientific and clinical expertise

Centre Hospitalier Universitaire De Grenoble (CHUGA)

This service provides access to health data from Clinical Data Warehouses of CHU Grenoble-Alpes. It includes datamart building (cohort and document selection, mapping to standard...) and data qualification (extraction of clinical variables, data cleaning, clinical consistency checking...) steps. In this way, the service offers companies an opportunity to access healthcare data and/or descriptive statistical analyses.​ This service involves only structured data extraction and pre-processing. In cases where the data is unstructured (e.g., requiring natural language processing for text, feature extraction from images, etc.), a specialized algorithm development service will be required (see our service "Algorithm development" for more details).​ An extension of the study to other clinical data warehouses from the TEF consortium can be considered in a second time. Prerequisite : To have data access, it is mandatory to fullfil the regulatory package asked by the French regulatory authorities* and a signed contract between the SME and the hospital. Furthermore, our services "Feasability study" and "Methodological advising" must have been previously conducted.​ Method Description: The service includes a minimal mandatory task set. Optional tasks can be jointly selected depending on the SME needs and available ressources: - Datamart building - Patient selection (cohort) [mandatory] - Selection of data of interest [mandatory] - Data qualification steps - Extraction of variables of interest [optional] - Data cleaning [optional] - Clinical consistency check by expert [mandatory] - Annotation/segmentation [optional] - Descriptive statistical study [optional] - Confidentiality control [mandatory] - Matching with other databases (i.e., SNDS) [optional] - Deployment of methods on another warehouse [optional] - Datamart availability on Hospital platform (CHU platform) [Standard offer] Method reference: Based on a scientific reference or a method designed by CHU Grenoble Alpes, as well as on methodologies provided by WP6. Provision by respecting General Data Protection Regulation (GDPR), AI Act, Good Clinical Practice (GCP) and french legal framework *Regulatory package: - Approval from the CNIL (Commission Nationale de l'Informatique et des Libertés) - Favorable scientific opinion (provided internally in the hospital by a scientific committee) - Favorable ethical assessment (provided internally in the hospital by an Institutional Review Board (IRB))

Centre Hospitalier Universitaire De Grenoble (CHUGA)

This service tend to offer a scalable platform to access dataset by the SME taking into account its infrastructure requirements and french legal framework.​ Prerequisite : The dataset must exclusively originate from our data warehouse. Method Description: Depending on the SME needs and available ressources, this service may include all or part of the following task list: - Deployment of the dataset on an environment outside Clinical data Warehouse Method reference: Provision by respecting General Data Protection Regulation (GDPR), AI Act, Good Clinical Practice (GCP) and French legal framework

Centre Hospitalier Universitaire De Grenoble (CHUGA)

This service offers method development for tasks at different processing levels . With this service, companies can benefit from clinical and data science expertise to facilitate the entire healthcare data processing process, including raw data cleaning, extraction of relevant features (pre-processing), statistical analysis and implementation of advanced algorithms in some cases. In particular, we provide specific capabilities including text processing using NLP techniques, feature extraction from images through both Machine Learning and Deep Learning algorithms.​ Prerequisite : The dataset must exclusively originate from our data warehouse. Our service "Data provision and analysis" must simultaneously be conducted. Method Description: The service includes: - Drafting of functional specifications [mandatory] - Development of data exploitation methods [mandatory] Method reference: Implemented methods will integrate General Data Protection Regulation (GDPR), AI Act, Good Clinical Practice (GCP) insights.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

This service will offer the possibility for SME to navigate interactively throught datasets thanks to an API developed within the CHUGA. It allows to select interactivly data and to visualize it thanks to BI tools. A short period of training is needed to be fully autonomous and able to exploit the full potential of the app. Method Description: Deployment of an API on a secure environment to navigate and vizualize interactively data.

Centre Hospitalier Universitaire De Grenoble (CHUGA)

The role of this service is to support the promotion and exploitation of research undertaken from an academic point of view. In particular, this involves proofreading and writing scientific articles, as well as participating in scientific conferences. The scientific commercialization service is therefore essential to ensure the dissemination and visibility of research results.​ Prerequisite: The study must have been conducted thought our other services. Method Description: Depending on the SME needs and available ressources, this service may include all or part of the following task list: - Scientific article writing [optional] - Proofreading and advice on writing scientific articles [optional] - Participation in scientific events (conferences, etc...) [optional] Method reference: Based on scientific and clinical expertise

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

The service provides access to high-quality, annotated clinical datasets that have been curated and enriched to ensure relevance, quality, and suitability for healthcare research, development, and innovation, that are relevant for testing purposes and also for retraining algorithm models. These annotated datasets enable SMEs to validate their products, such as machine learning algorithms or medical devices, using real-world clinical data.

Centro Hospitalar De Sao Joao Epe (CHSJ)

The service offers SMEs access to high-quality, annotated clinical datasets with relevant clinical for testing purposes, also for re-train algorithm models. These annotated datasets enable SMEs to validate their products, such as machine learning algorithms or medical devices, using real-world clinical data.

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

This service offers SMEs access to curated clinical datasets along with expert guidance in selecting relevant variables for their specific use cases. Levaraging the hospital's extensive data resources and by thoroughly understanding the clinical requirements and objectives of each study, it ensures that the chosen variables are relevant, high-quality, and fit for purpose, thereby enabling more robust, efficient, and clinically meaningful analyses. This service assists SMEs in identifying the most pertinent variables from clinical datasets to support their product development efforts.

Centro Hospitalar De Sao Joao Epe (CHSJ)

This service offers SMEs access to curated clinical datasets along with expert guidance in selecting relevant variables for their specific use cases. Levaraging the hospital's extensive data resources and by thoroughly understanding the clinical requirements and objectives of each study, it ensures that the chosen variables are relevant, high-quality, and fit for purpose, thereby enabling more robust, efficient, and clinically meaningful analyses. This service assists SMEs in identifying the most pertinent variables from clinical datasets to support their product development efforts.

Laboratoire National De Metrologie Et D'Essais (LNE)

With the development of AI models in most sectors of society, the importance of the data used to train and test these models has a been an important concern for the AI supplier. Understanding the quality of the datasets used, especially in sector such as the medical domain where data can be hard to get, is thus a prerequesite to ensure the correct development of AI models and building trust regarding these approach for society. This service aims to answer this challenge by assessing the quality of datasets provided by the client. The features of the datasets that will be analyzed are based on agreed definition by the AI community: completeness, balance, diversity, accuracy... The service will help the client that want to ensure the quality of a dataset and understand the features of the data, thus answering the requirements regarding data quality of the AI regulation. A report will be provided to the customer at the end of the service, explaining the methodology and detailling all the analysis and conclusions of the study. The service generally take around one month to be provided once the data has been delivered to LNE. Work is generaly done directly on LNE infrastructure, but in case of confidentiality requirements, it is possible to adapt the work.

Laboratoire National De Metrologie Et D'Essais (LNE)

Development of an evaluation method for the AI solution: given the specifications and context of application of the AI system, the test will provide the evaluation plan to assess the performance of the system, in order for the customer to realize its own evaluation. This service will be based on the expertise of the LNE in creating evaluation plan given an AI system. The evaluation plan will contain the specification of the evaluation tasks, the creation of the test data, the metrics, and the evaluation protocol. All these elements will be used by the customers to conduct the evaluation of the AI system.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Combinatorial optimization solution for processes, scheduling and logistics optimization. Provide expertise on how to address large scale routing, scheduling, logistics and other combinatorial optimisation problems using constraint-based local search. Keywords: Resource Planning, Patient Transportation, Process Optimasation

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service offers a comprehensive overview of the medical device market, including insights into product pipelines and category rankings on a global scale. Keywords: Medical Device; Market; Analysis

Univerzita Komenskeho V Bratislave (UK BA)

(1) The laboratory provides microsatellite instability (MSI) in FFPE cancer tissue in low throughput screening methods, including PCR and fragment analysis. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing in GeneMapper v.6 software. (2) Next, the laboratory provides DNA methylation analysis in promoter regions of genes in low and medium throughput screening methods, including pyrosequencing and/or MS-MLPA and fragment analysis. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing in Cofalyser.net softvare. (3) The laboratory also provides comparative genomic hybridization (CGH), as well as single nucleotide polymorphism (SNP) detection by microarray that enables identification of aneuploidies, microdeletions, microduplications, as well as other types of chromosomal aberrations across the genome. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing. (4) The laboratory provides detection of single nucleotide variation from various types of samples by real-time PCR or Sanger sequencing. The method is also usefull for verification of whole genome sequencing results. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing. (5) The laboratory also provides targeted sequencing of selected parts of the genome (e.g. TruSight Oncology 500 panel), followed by somatic or germline analysis. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing in Pierian software with clinical interpretation.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Platform:** [DPM-Research](https://www.iis.fraunhofer.de/de/ff/sse/health/mobile-health-lab/managementsystem-klinische-studien.html): A customizable eCRF platform that streamlines data and patient management and documentation in clinical studies, aligned with international standards and data protection regulations. **Who Can Benefit:** - Clinical Researchers: For streamlined data management processes that support robust research methodologies and regulatory compliance. - Regulatory Compliance Specialists: To ensure that clinical studies adhere to required international and local regulations, minimizing risk and enhancing credibility. - Healthcare Organizations: To manage clinical data effectively, improving research outcomes and operational efficiencies. **Key Features:** - Customized Data Management Solution: Provides a tailored data management and documentation platform designed to support clinical research studies. - eCRF Platform: Offers an electronic Case Report Form (eCRF) system customized for collecting and managing clinical research data efficiently. - Compliance with Standards: Ensures all studies are conducted in compliance with ISO 14155 and GDPR (DS-GVO), guaranteeing high standards in clinical investigation and data protection. **Possible Applications:** - Clinical Studies: Supports the management of clinical trial and patient data, ensuring accuracy, integrity, and regulatory compliance throughout the research lifecycle. - Data Documentation: Facilitates comprehensive data collection and documentation, improving the reliability and reproducibility of clinical research findings. **Who we are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Karolinska Institutet (KI)

This service is a follow up to the Data Feasibility Study, and can only be delivered after that service has been completed and a potential data set that meets the requirements has been identified. Note that an additional fee, not covered by the call's price reduction, may apply. ## Overview Acquiring existing data sets—full-service data management. This service makes data sets identified in the Data Feasibility Study available to SME’s for TEF-project purposes, such as validation and testing of AI systems. Data can be collected from routine health records and local, regional, and national databases in collaboration with healthcare providers in Sweden. We provide expertise and technical support in the following areas: • Project design & management • Ethical application support • Data assembly • Data cleaning, annotation, anonymisation or pseudonymisation ### How can the service help you? Access to existing health data can help you validate your AI solution without needing to generate new data. We provide access to high quality datasets for validation and testing of your AI system, to facilitate placing it on the market and to increase its market readiness level, for example by supporting regulatory approval and building stakeholder/healthcare-provider confidence. Validation and testing data can be used for independent performance evaluation of your AI system in a real-world or simulated environment. Validation and testing without needing to generate new data frees up time to focus on model optimization and deployment. ### How will the service be delivered? The service will be delivered according to established ethical agreements and guidelines, in collaboration with the SME and researchers from the Swedish TEF-Health node. Data usage is facilitated through a secure virtual environment managed by Karolinska Institutet, ensuring the highest standards of data protection. --- ## Additional information ### Provider description The Swedish TEF-Health node is a collaboration between Karolinska Institutet, SciLifeLab and RISE, and is led by Karolinska Institutet. Together, we offer world-leading services with our unique collection of core facilities. We grant services in expert consulting, virtual- and physical testing in the range of in vivo imaging, ex vivo OMICS, pharmaceutical development, simulated healthcare environments, AI-system validation and development, advanced data analysis and other data-driven life science. ### Technical description Datasets identified in the Data Feasibility service will be made available to suit your AI system, supporting the testing and validating of your solution. The data will be tailored to your specific request to ensure it is compatible with your AI system and its real-world use, and with full support from Karolinska Institutet to ensure compliance with all relevant regulations, including GDPR and national Swedish regulations. Upon completion of this service, you will receive an evaluation of the performance of your AI system. ### Service customization The service can be customised according to your specific needs, taking into account which type of data you require. --- ## Use case example An SME developing an AI-based diagnostics system requests access to the retrospective datasets identified in the Data Feasibility Study service to independently validate the solution. Under an ethical agreement with the Swedish TEF-Health node, the service assembles and prepares the data and provides access through a secure virtual environment at Karolinska Institutet, where the system is tested in simulated and real-world scenarios. The resulting performance evaluation demonstrates the system's accuracy and reliability, supporting the SME's regulatory approval process and market entry.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Challenge : The client may request from a software solution provider that a copy of the source code be held by a neutral third party. In the case of AI solutions, training data may also be involved. Security and confidentiality are obviously important. Our strength : CETIC routinely offers a secure procedure for retaining the source code of software and can extend this to AI-based software by managing and preserving the datasets used, thus demonstrating the ability to reproduce the protected software. This service enables a procedure to be put in place to preserve the source code of AI-based software by a trusted third party. This service will manage and preserve the datasets used to develop AI models. Keywords: Software Escrow services

Politecnico Di Milano (POLIMI)

Support in the functional evaluation of Human-Robot Interface (motion capture, EMG, EEG, etc) Costs estimation for both prototype development and volume manufacturing to support SMEs/start-up plan and budgeting throughout the product development lifecycle. Keywords: Cost estimation, Prototype development, Volume Manifacturing, Budget Planning, Manufacturing Costs, Product Development Lifecycle, Cost Optimization;

Politecnico Di Milano (POLIMI)

This service provides recommendations on how to implement the explainability models on the AI system of interest. The implementation can also be performed by POLIMI expert. Keyword: Explainaibility of AI algorithm

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : Artis Zeego (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : CT SCAN (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : MRI (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : US, (pricing doesn't include human resources that must be present in support)

Univerzita Komenskeho V Bratislave (UK BA)

Laboratory infrastructure includes flow cytometer/sorter FACS Aria II c, fluorescence microscope Olympus iX72, light microscope, BSL-2 laminar hoods, cell incubators, and electrophoretic equipment for Western blot. The laboratory develops and prepares unique in vitro models (3D and 2D cancer cell lines) derived from human tumor tissue.

Hospices Civils De Lyon (HCL)

Formative evaluation of surgical robot prototype (under development) in order to improve usability (according to IEC 62366-1). This packaged service includes : - Operating room rental - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including design improvement recommendations and potential new use-related risks to mitigate Prices range is indicative and depends on testing protocol complexity and particpants number

Hospices Civils De Lyon (HCL)

Technical testing of AMR (Autonomous Mobile Robot) for logistics: - performance and acceptability in realistic environment with representative users This packaged service includes : - Room rental for testing - Participants (healthcare professionals) recruitment within our hospital if required - Protocol elaboration - Testing phase - Evaluation report, including recommendations if applicable Prices range is indicative and depends on testing protocol complexity and particpants number

Hospices Civils De Lyon (HCL)

Technical testing of surgical robot prototype in order to assess : - performance in realistic settings (using phantoms) - technical integration within operating theatre (interoperability, space constraints, etc.) This packaged service includes : - Operating room rental - Participants (healthcare professionals) recruitment within our hospital if required - Protocol elaboration - Testing phase - Evaluation report, including recommendations if applicable Prices range is indicative and depends on testing protocol complexity and particpants number

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Services: - Full body motion analysis on a treadmill - Gait analysis with real-time feedback in virtual reality environments

Politecnico Di Milano (POLIMI)

Generation of synthetic virtual cohorts leveraging statistical and data-driven methods and featuring realistic anatomies, flow fields, and boundary conditions. These virtual populations can serve multiple purposes, from in silico trials for testing new devices and procedures, to training large deep learning models for disease-specific tasks and discoveries. Method Description: The service provides synthetic datasets for AI algorithm development, AI algorithm testing and digital twin based simulations (fluidynamic/structural simulations, fluid structure interaction) Method reference: https://doi.org/10.1016/j.cmpb.2023.107468

Zilinska Univerzita V Ziline (UNIZA)

Provision of high-performance computing infrastructure powered by NVIDIA GPUs, enabling SMEs and researchers to train and test AI models in a scalable and secure environment. This service supports deep learning, computer vision, and large dataset processing tasks. Technical details:NVIDIA GPUs, remote access, Docker support, secured environment. Use cases/examples: SMEs without adequate training machines can rent full power of the high-end computers. The computer operates a platform for data storage, model training and evaluation.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

As a non-profit and accredited centre, our experts provide a neutral and independent technical advice and support along the design and implmentation process. Service includes SotA (State of the Art) analysis and positioning, coaching on design choices, studying of alternatives for solutions involving embedded systems, elaborating design reviews, software and hardware architecture reviews, components selection, recommandations, analysis, etc. Keywords: SotA, design review, technical advice, independent expertise

Politecnico Di Milano (POLIMI)

Providing expertise in the field of medical robotics (exoskeletons and surgical robotics), to be eventually tailored to specific projects: 1) Definition of applications objectives 2) Support to the mechanical design of the robotics, mechanical design and embedded sensors 3) Firmware integration and software control 4) Technical, dry and experimental validation Keywords: Robotics Control, Robotics Design, Exoskeleton, Surgical Robot

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Test and validtation by users in simulated or real OR environment of your medical device

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Clinical acquisition of images in an OR using different imaging modality : -US -EUS -Endoscopy -MRI -CT SCAN -Artis Pheno *Clinical data collection must be included in a clinical study that IHU can design according to your needs*

Univerzita Komenskeho V Bratislave (UK BA)

Cell microscopy - Confocal laser scanning microscop Zeiss LSM 880 (Fluorescence microscopy, Real-time recording, Time-resolved microscopy, Whole tissue scanning, Image processing)

Univerzita Komenskeho V Bratislave (UK BA)

Small animal MRI imaging: Bruker BioSpec 70/20 USR 7 T preclinical (MRI, MRS, MRSI, relaxometry, iron quantification, Image processing and analysis)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Preclinical acquisition of images in an OR using different imaging modality : -US -EUS -Endoscopy -MRI -CT SCAN -Artis Zeego *Preclinical data collection must be included in a preclinical study that IHU can design according to your needs*

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

We specialize in developing and evaluating medical image analysis models using deep learning algorithms for tasks such as binary classification and anomaly localization. Our AI models are rigorously tested and validated in real-world hospital settings through prospective studies, ensuring their accuracy and reliability. How can the service help you? We aim to improve the clinical relevance and effectiveness of our AI models by leveraging our experience of real-world datasets achieved through close collaboration with healthcare professionals. This hands-on approach allows us to develop and evaluate AI models in real-world contexts, ensuring that they meet the specific needs of healthcare applications and work reliably in clinical environments. How will the service be delivered? The service will be delivered in several steps: - Consultation & Needs Assessment : Understanding your specific requirements and use cases. - Model Development & Optimization : Designing and optimizing AI models for medical imaging tasks. - Testing & Validation : Testing the models with real-world datasets to ensure performance and reliability. - Pretrained Pipeline Delivery : Providing custom pretrained pipelines for your needs. - Ongoing Support : Offering continuous support to refine and improve the models based on feedback.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Along the innovative product/solution development pathway relevant go-no-go decisions should be taken into account. To ensure the suitability of the design and/or the product/solution market receptiveness, critical milestones should be checked in early phases to anticipate the health technology optimal launch. By granting the product/solution a KOL validation, by clinical experts through a systematic assessment approach, in a timely manner, will reduce the risk of failing the next steps of the way. IPN, in collaboration with Coimbra University Hospital – Unidade de Saúde Local de Coimbra (ULS-C) and the synergies settled through the TEF-Health partnership, counts on the expertise of high-tier health clinical professionals to provide new technologies assessment in a 3-step way, 1. Preliminary evaluation: the KOL self-assesses the product/solution provided information, to evaluate its medical purpose assumptions? If it answers an unmet medical need? competitor(s) in the market? Strengths/weaknesses of the technology? etc. 2. Short meeting: a 1:1 one-hour meeting, where the KOL is briefed with a 10-15 mins. demonstration of the product/solution, followed by a discussion of the concerning queries. 3. Expert assessment report: a report is issued addressing insight on the raised hot topics, including suitability strengths, weaknesses, opportunities and threats analysis (SWOT) analysis and useful recommendations/ suggestions to be considered.

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Neuro Imaging platform includes: -MEG/EEG (Elekta Neuromag) : 204 gradiometers, 102 magnetometers, 128 EEG channels. - MRI/MEG-compatible EEG amplifier (Brain Products) : 64 channels. - MRI 1.5T (Siemens Espree) - Audio, visual and sensitive stimulation equipment - Dedicated HPC workstation for real-time signal processing The service offers to conduct a clinical study with MEG/EEG/MRI Imaging to generate new brain-related data: - Data acquisition & analysis +/- technical expertise. - Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. - Example: provide new clinical data to assess/validate the performance/robustness of an AI system in a specific intended use Keywords: Neuro Imaging; MRI; MEG; imaging data acquisition

Univerzita Komenskeho V Bratislave (UK BA)

Laboratory provides low or medium throughput screening of selected bacterial and/or viral strains from various sample material, including sample preparation to analysis by real-time PCR. The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing.

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Overview This service offers a specialized Mood Induction and Depression Study Laboratory equipped with state-of-the-art multimodal sensor technology. It provides a highly controlled environment for conducting psychological interventions and assessing emotional responses or depressive symptoms, particularly through mobile health applications. By integrating high-resolution video, depth sensing, and advanced non-contact radar systems, we capture fine-grained behavioral responses, including facial expressions and body posture. The laboratory also records critical physiological biosignals such as muscle activity (EMG), cardiac rhythms (ECG), and respiration. This service enables startups and healthcare developers to thoroughly evaluate digital therapeutics, affective computing models, and remote monitoring tools in a standardized, clinically relevant setting. How can the service help you? For companies developing mobile mental health interventions, affective computing algorithms, or non-contact vital sign monitors, acquiring synchronized behavioral and physiological data is a major challenge. This service provides high-fidelity, ground-truth data for mood induction and depression studies. After using our facility, you receive a comprehensive dataset that links your interventions to precise physical, behavioral, and autonomic responses, letting you validate your solutions and refine AI-driven assessments. How will the service be delivered? The service is delivered physically at our specialized laboratory facilities. Execution time depends on the specific intervention protocols and the cohort size. Our expert team configures the recording infrastructure—including camera arrays, radar systems, and biosignal hardware—and integrates them with the workflows under evaluation. Data collection is conducted under strict ethical and clinical guidelines. Upon completion, clients are provided with securely processed, synchronized, and annotated datasets. Additional information Provider description We represent a leading research node within the TEF-Health consortium, specializing in artificial intelligence, machine learning, and digital health innovations. Our team possesses deep expertise in automated movement analysis, multimodal behavioral tracking, and complex data synchronization. With advanced facilities dedicated to biomedical engineering and affective computing, we offer SMEs expert guidance and state-of-the-art testing environments to develop, validate, and certify AI-driven healthcare solutions and wearable technologies. Technical details The laboratory is built around a comprehensive suite of contact and non-contact sensors designed to monitor mood and depression-related markers seamlessly during mobile app interventions. Behavioral & Posture Tracking: The setup features 2 high-resolution RGB Sony cameras and 1 Azure Kinect depth camera for robust 3D human pose estimation and facial expression analysis. This is supplemented by 2 standard webcams and a wireless microphone pair for comprehensive audio-visual tracking. Mobile Ecosystem: Dedicated devices (2 iPhones, 1 iPad, 1 Samsung tablet) are maintained specifically for deploying and testing iOS and Android mobile health (mHealth) applications. Advanced Radar Systems: We utilize non-contact continuous-wave (CW) radar systems—including a 61 GHz EmRad system (TU Hamburg) and a 24 GHz GUARDIAN system (FAU Erlangen-Nürnberg)—to enable unobtrusive vital-sign and micro-movement monitoring. Physiological & Biological Measurement: Standardized assessment of biosignals (EMG, ECG, and RSP) is conducted. The laboratory also supports the collection of biological specimens, processed in accordance with Bio S2 standards. Software Integration: Data acquisition and analysis are managed utilizing Biopac Acqknowledge alongside custom multimodal synchronization pipelines. Service customization The service is highly adaptable to the specific needs of your clinical study or product validation. Clients can choose to utilize the full multimodal suite or select specific sensing modalities—for instance, relying solely on non-contact radar and depth cameras for privacy-preserving monitoring, or focusing entirely on app-based interactions paired with high-fidelity ECG. Camera configurations, mobile app integration steps, and biological sampling protocols can all be tailored to meet your specific technical requirements.

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Overview This service provides full-body motion analysis in a stationary environment, specifically tailored for sports and complex biomechanical tasks. The facility relies on a high-precision optical motion-capture tracking volume, originally configured as an advanced golf simulator, that is adaptable to a wide range of athletic movements. By combining a dense array of infrared cameras with high-speed RGB video and inertial sensors, the laboratory captures precise 3D kinematic data. This setup enables detailed assessment of joint angles, segment velocities, and technique execution, providing structured reference data for sports science research, markerless pose estimation training, and validation of athletic wearables. How can the service help you? Developing sports performance trackers, digital coaching applications, or AI-based computer vision models for movement analysis requires precise 3D spatial data. This service provides the necessary gold-standard optical tracking data to validate external systems. Before using this facility, developers often lack the tracking accuracy needed to verify their algorithms. After using the service, clients receive highly accurate 3D coordinate data of joint centers and body segments, allowing them to calculate error margins in their own hardware or software solutions and ensure compliance with relevant performance or medical standards. How will the service be delivered? The service is executed physically at the laboratory facilities in Erlangen, Germany. Sessions are structured around the specific sports movement or biomechanical task being analyzed. The engineering team handles camera calibration, retroreflective marker placement on the participant (if optical tracking is used), and system synchronization. Following the capture session, the 3D marker trajectories are reconstructed, cleaned, and exported for the client. Additional information Provider description Operating under the Department of Artificial Intelligence in Biomedical Engineering at Friedrich-Alexander-Universität Erlangen-Nürnberg, this facility is a service-provider node within the TEF-Health consortium. The research group focuses on machine learning, biomechanical modeling, and digital health. The team provides testing environments and methodological support for evaluating medical devices and health technologies. Technical details The laboratory uses a hybrid optical-inertial tracking setup optimized for fast, complex movements. Optical Tracking System: The core motion-capture volume (the golf-simulator setup) uses 12 Vicon infrared cameras for precise 3D marker tracking, complemented by 2 Vicon RGB cameras for synchronized high-speed video recording and visual reference. Inertial Tracking: 10x Vicon BlueTrident IMUs are available to track movements outside the optical volume or to provide hybrid optical-inertial data for algorithm training. Auxiliary Equipment: A dedicated camera (Maike) is available for additional recording angles, and 2x Apple iPhone SE 2022 devices are used to test mobile applications. Software: Data acquisition and reconstruction are handled via Vicon software. Agisoft Metashape Pro is available for advanced photogrammetry and 3D environment/subject modeling. Standards: Procedures and data management can align with Medical Device Regulations EU/2017/745 for relevant clinical applications. Service customization The capture volume and sensor configuration are fully customizable. Clients can define specific marker sets (from minimal lower-body sets to full-body anatomical models) depending on the movement being analyzed. The service can also be configured to collect synchronous optical and IMU data to help developers train sensor-fusion algorithms.

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Motion laboratory rental for prototype testing : usability/technical testing and evaluation of medical device [no patients included]. Examples: Study of an exoskeleton's movements ; analysis of "fine" surgical robots mouvements. Motion lab equipped with: - 8 infrared cameras, 2 high-resolution cameras, 2 plantar pressure sensors - Wireless pressure sensors and non-invasive electromyographic sensors (system Cometa) - GAITrite system (Spatio-temporal gait parameter analysis system) - Dedicated workstation and data-storage for daily-use analysis Keywords: motion; rental; technical testing; medical device evaluation

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Within the motion analysis laboratory, this service can offer: 3D motion analysis system: - full body motion analysis - Gait analysis thanks to a full GAITrite system - definition of an anatomical model - motion sequence validation with an exoskeleton - movement tracking of robotics Data acquisition can be completed with data analysis service. Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. Examples: clinical study to validate an exoskeleton on patients ; to validate a rehabilitation device on patients, ... Keywords: motion; GAIT analysis; robotics; exoskeleton; medical device validation

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Movement laboratory equipped with 3D movement analysis system featuring infrared cameras and force plates. Plantar pressure sensors, isokinetic dynamometer, breath gas analyzer, ultrasonic imaging and body composition analyzer. Helping with research questions (user, customer experience, etc.) Helping with the research design and conducting the research, analysis. Video recording

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Neuro Imaging platform includes: -MEG/EEG (Elekta Neuromag) : 204 gradiometers, 102 magnetometers, 128 EEG channels. - MRI/MEG-compatible EEG amplifier (Brain Products) : 64 channels. - MRI 1.5T (Siemens Espree) - Audio, visual and sensitive stimulation equipment - Dedicated HPC workstation for real-time signal processing The service offers to conduct a clinical study with MEG/EEG/MRI Imaging to generate new brain-related data: - Data acquisition & analysis +/- technical expertise. - Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. - Example: provide new clinical data to assess/validate the performance/robustness of an AI system in a specific intended use Keywords: Neuro Imaging; MRI; MEG; imaging data acquisition

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service provides access to a network of organizations within the Portuguese health ecosystem and offers support in identifying and connecting with specific partners critical to the development of innovative solutions. Keywords: networking, partnerships

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Service Keywords:** Expertise in Human Movement, Neurological Diseases, Project Design, Clinical Study Design, Scietific-Technical Constulting, Data Evaluation, Data Acquisition, Technical Support, Performance Evaluation/Reporting, **Equipment:** - 10x Vero Cameras (infrared) - 2x VUe Cameras (visible) - 2x AMTI Optima Pressure Plates - Cometa Wave Plus (EMG): 12x MiniWasve EMG Sensors, PICO EMG Sensors - 2x Blue Trident IMU (low and high g Accelerometer, Gyroscope, Magnetometer) **Who Can Benefit:** - Data Scientists and AI Researchers: To obtain high-quality datasets for training and validating AI models that can identify and predict gait abnormalities and differentiate between various movement disorders. For designing, implementing, and testing algorithms that automate the analysis of gait patterns, thereby improving efficiency and accuracy. - Healthcare Technology Innovators: To integrate AI-driven insights into wearable devices or diagnostic tools that enhance patient monitoring and care delivery. - Clinical Researchers: To explore AI applications in clinical trials, enhancing understanding of treatment impacts on gait and mobility in various disorders. - Software Developers: For creating user-friendly AI software interfaces that clinicians can use to easily interpret results and apply AI insights to patient care. - Rehabilitation Professionals: To utilize AI-enhanced feedback for developing adaptive rehabilitation protocols that respond to instrumented changes in gait patterns. - Biomedical Engineers: For advancing AI-driven biomechanical analysis tools that can be used in designing prosthetics, orthotics, and assistive devices. **Key Features:** - User-Friendly Interface: Intuitive software interface for both technical and non-technical users, ensuring ease of use for engineers, clinicians, and other healthcare personnel. - Comprehensive Reporting: Provides detailed reports and visualizations of gait characteristics, such as stride length, speed, and variability, to quantify gait patterns and draw clinically relevant conclusions. - Experienced Personnel: Gain access to a team of specialists with extensive experience in analyzing gait and movement patternsassociated with neurological conditions. Our experts possess in-depth knowledge and skills to provide accurate assessments and valuable insights, supporting the development of your application in the field of neurological disorders. - Directly Attached to Clinic: Patients and physicians can easily access the state of the art facility for gait and movement analysis. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Univerzita Komenskeho V Bratislave (UK BA)

Full-service metabolomics analysis in-vitro and ex-vivo using NMR spectroscopy. Proficiency in instrumentation performance, metabolomic measurement protocols and data analysis for clinical, academic and indystry applications.

Karolinska Institutet (KI)

The Unit: Clinical Genomics Stockholm (https://www.scilifelab.se/units/clinical-genomics-stockholm/) This infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Clinical Genomics Stockholm unit is a research infrastructure for large-scale, genomics-based analyses using next generation sequencing technologies. The unit assists in translational research projects, in the translation of genomics-based tools to routine clinical care and also aims to improve the capability for national microbial surveillance and for pandemic preparedness. The Service: Non-human genome sequencing Sequencing of bacterial or viral whole genomes with the possibility of sequence analysis and strain typing. Sequencing of SARS-CoV-2 amplicons. Sequencing of metagenome samples (with PCR-free protocol). This service encompasses: o Consultation (Project design, Target capture design) o Sample management o DNA& RNA sequencing (microbial genomes, metagenomics) o Bioinformatics (Bioinformatic analysis on data generated at CG) Equipment Our unit has access to specialized equipment that enable us to factilitate the translation of new high-throughput techniques into clinical use. These include, but are not restricted to: • Various automatic robotic systems (BRAVO NGS Workstation, Hamilton NGS Star) • Various systems for QC, quantification and fragment analyses (TapeStation, Quantification using fluorescent assay (Qubit, Quantit)) • Instrumentation for real time PCR and ddPCR (BioRad qPCR) • Instrumentation for Multispectral imaging (Saphyr optical mapper) • Sequencing platforms: o Illumina (NovaSeq 6000, NovaSeq 6000 Dx, NovaSeq X) o Nanopore (PromethION “access via NGI”) o PacBio (Revio)

Karolinska Institutet (KI)

The Unit: Chemical Biology Consortium Sweden (https://www.scilifelab.se/units/cbcs/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Chemical Biology Consortium Sweden (CBCS) is a national research infrastructure offering an extensive portfolio of services - from computational and organic chemistry to phenotypic small molecule screens in cells and model organisms, cell painting and functional precision medicine. The mission of CBCS is to provide a state-of-the-art platform and expertise for the generation of high-quality bioactive chemical tools (small organic molecules) for applications within life science research in general and with the ultimate goal to explore complex biology. Our units comprise compound handling labs (hosting the SciLifeLab Compound Collection of ca 350,000 molecules), screening labs (microtiter format liquid handling robotics and a wide range of plate readers), and chemistry labs (equipment and instrumentation for organic chemistry synthesis and analysis). The service: Open access to instrumentation Possibility to rent specialised laboratory equipments, and also to get your own equipment tested by our team of scientists and lab experts. Scientific writing support and reporting can also be offered if needed.

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Conduct an interventional clinical study within clinical research facility CEA-Clinatec : Operating room and hospitalisation room, with access to Grenoble-Alpes University Hospital's network of clinicians. Clinical and regulatory support to set up and submit the clinical study within French regulatory framework. Operating room equipped with: - Neuro navigation robotic system ROSA - Intraoperative 1,5T MRI (Espree, Siemens): positioned on a rail to go into the operating room during surgery - Mobile X-ray unit (general Electric) - Stereotaxis interventional radiography chain (Apelem) Keywords: operating room; clinical study; surgery; neurology; medical device validation

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

Facility rental for: - protoype testing: usability/technical testing and evaluation of medical device [no patients included] - MRI compatibility evaluation of medical devices Rental of the operating room including: - surgical and anesthesic equipment MRI-compatible - anesthesic area - hospitalisation rooms if needed OR equipped with: - Neuro navigation robotic system ROSA - Intraoperative 1,5T MRI (Espree, Siemens): positioned on a rail to go into the operating room during surgery - Mobile X-ray unit (general Electric) - Stereotaxis interventional radiography chain (Apelem) Keywords: operating room; medical device evaluation

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, the Brain Molecular Imaging Centre (BMIC), supports clinical and pre-clinical research studies involving PET experiments. For large animal preclinical studies: the GE Discovery MI 5 PET/CT is a whole-body PET system designed for increased field of view to enable exceptionally high sensitivity, allowing AI, deep learning image reconstruction. The PET system is mainly used in humans and larger animals such as pigs. The system specifications are Transaxial FOV: 70 cm, Axial FOV: 25 cm, Spatial resolution: ~5 mm. Radiopharmacy CF, we then provide full service in conducting PET experiments. In this service, we offer our highly trained staff comprising PET camera operators, medical physicists, research nurses and physicians, as well as specialised staff conducting experiments with animals. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/bmic

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility Karolinska Experimental Research and Imaging Centre (KERIC), has two PET-CT systems for animal imaging (Mediso nanoScan PET-CT). They are equipped with single-mouse, single-rat, or double-mouse beds. Four mice can be run simultaneously with exceptional image quality. The PET modules (spatial resolution 0.8mm) and a CT module (min. voxel size: 10-34 µm). KERIC collaborates closely with the Radio Pharmacy Core Facility (RCF), which allows us to deliver freshly produced radioactive ligands within a minimum time frame. In this service, we offer full support in project consultation, ethical permits, module technical support, animal technicians and data analysis. We can host animals directly or indirectly through collaboration within KU (AKM) and other animal labs. For more information, visit the website: https://ki.se/en/research/pet

Karolinska Institutet (KI)

Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility Karolinska Experimental Research and Imaging Centre (KERIC), we have a preclinical 9.4T Bruker USR 94/30 MRI combined with Mediso nanoScan PET-CT systems for small-animal imaging equipped with single-mouse, singe-rat, or double-mouse beds. The PET module has a spatial resolution of 0.8mm. The state-of-the-art 9.4T MRI is equipped with three gradient bore sizes to arrange an effective inner diameter of 20cm (large animals), 12cm (medium animals) or 6cm (small animals). Methods in anatomical imaging, fMRI, Ex vivo, Pharmacological MRI and Cardiac imaging (CINE). For the mouse brain, a 4-channel phased array cry-coil drastically increased signal-to-noise. KERIC collaborates closely with the Radio Pharmacy Core Facility (RCF), which allows us to deliver freshly produced radioactive ligands within a minimum time frame. In this service, we offer full support in project consultation, ethical permits, module technical support, animal technicians and data analysis. We can host animals directly or indirectly through collaboration within KU (AKM) and other animal labs. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/keric

RISE Research Institutes Of Sweden

RISE Research Institutes of Sweden AB in Södertälje works with pharmaceutical R&D including preclinical research of new candidate drugs. From design to production in the same testbed: - Preclinical in-vitro and in-vivo studies to study target and non-target toxicology. - Drug formulation and new therapies with small molecules, biologics including proteins, oligonucleotides, peptides, mRNA, DNA etc. - Chemical Process development and GMP production to clinical studies. - In vivo studies integrated with bioanalytical and pathology services, supporting from early discovery to preclinical safety testing. - Chemical analysis and characterization, including impurity analysis and stability. - Green chemicals and formulation. Keywords: Testbeds, toxicology, regulatory safety, process chemistry, drug delivery, drug formulation, drug synthesis, bioassay, drug analysis

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

Clinical investigations involve rigorous testing of AI technologies or healthcare solutions in real-world clinical environments. The investigation involves one or more human subjects, and the goal is to assess the clinical performance, effectiveness or safety of a medical device. ULS Coimbra act as an Investigation site, providing: - Principal invistigatior qualified by education, training and experience - Trained research staff - Acess to specific patient population - Site facilities that comply with requeriments of intended use of device - Hospital Ethics Comittee submission - Site selection report documenting qualifications of the principal investigator and the suitability of the investigation site This service can be complemented with the support of CRO services.

Centro Hospitalar De Sao Joao Epe (CHSJ)

Clinical investigations involve rigorous testing of AI technologies or healthcare solutions in real-world clinical environments. The investigation involves one or more human subjects, and the goal is to assess the clinical performance, effectiveness or safety of a medical device. ULS São João act as an Investigation site, providing: - Principal invistigatior qualified by education, training and experience - Trained research staff - Acess to specific patient population - Site facilities that comply with requeriments of intended use of device - Hospital Ethics Comittee submission - Site selection report documenting qualifications of the principal investigator and the suitability of the investigation site This service can be complemented with the support of CRO services.

Centro Hospitalar De Sao Joao Epe (CHSJ)

ULS São João performs comprehensive functional testing to evaluate the performance and integration of healthcare technologies within clinical environments. The testing is carried out in order to ensure that the solution delivers its intended functions, seamless integrates with existing infraestructures and devices and maintains reliable performance under normal or demanding usage conditions. This packaged service includes: - Key functionality verification; - Real-world performance testing; - Integration with existing systems and devices; - Evaluation report including suitability for the clinical environment.

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

ULS Coimbra performs comprehensive functional testing to evaluate the performance and integration of healthcare technologies within clinical environments. The testing is carried out in order to ensure that the solution delivers its intended functions, seamless integrates with existing infraestructures and devices and maintains reliable performance under normal or demanding usage conditions. This packaged service includes: - Key functionality verification; - Real-world performance testing; - Integration with existing systems and devices; - Evaluation report including suitability for the clinical environment.

Centro Hospitalar De Sao Joao Epe (CHSJ)

Formative usability testing is not intended to evaluate the safety and performance of a device comprehensively. This services focus on an Iterative process where usability tests are carried out early and repeatedly during the development of the device. The goal of this service is to identify and correct any usability problems before the device is finalized, this means: Early identification of problems;Iteration and feedback; User involvement; Focus on improvement.

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

Formative usability testing is not intended to evaluate the safety and performance of a device comprehensively. This services focus on an Iterative process where usability tests are carried out early and repeatedly during the development of the device. The goal of this service is to identify and correct any usability problems before the device is finalized, this means: Early identification of problems;Iteration and feedback; User involvement; Focus on improvement.

Centro Hospitalar De Sao Joao Epe (CHSJ)

Summative usability testing assesses the final product’s usability and compliance with regulatory standards. The main objective is to evaluate the overall usability performance of the device, and not necessarily to identify specific problems to be corrected. This service ensures that the technology meets the needs of end-users, and aligns with clinical workflows.This packaged service can include: - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including design improvement recommendations and potential new use-related risks to mitigate

Unidade Local De Saúde De Coimbra EPE (ULS Coimbra EPE)

Summative usability testing assesses the final product’s usability and compliance with regulatory standards. The main objective is to evaluate the overall usability performance of the device, and not necessarily to identify specific problems to be corrected. This service ensures that the technology meets the needs of end-users, and aligns with clinical workflows.This packaged service can include: - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including design improvement recommendations and potential new use-related risks to mitigate

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Equipment:** - PHCT Mobile Gaitlab System Clinic: A complete mobile setup for detailed and accurate gait analysis, designed specifically for clinical use cases and supporting the aforementioned features and applications. - maphera®: A Fraunhofer technology revolving around easy and mobile acquisition of multimodal, patient-centered data in medical grade quality. Current sensors include ECG, PPG, EMG, IMU and any other modality you require, due to the flexible sensor interface of the maphera® system. - Polar H10 and Pro Strap: Long-term, mobile monitoring of heart rate and movement of subjects during any kind of activity in a real-world environment. **Who Can Benefit:** - Data Scientists and AI Researchers: Gain reliable datasets for developing AI models to identify and predict health abnormalities, enhancing the accuracy and efficiency of analysis. - Healthcare Technology Innovators: Integrate AI insights into wearable devices or diagnostic tools, advancing patient monitoring technologies. - Clinical Researchers: Employ AI applications in clinical trials to deepen insights into the effects of treatments on a multitude of physical disorders. - Software Developers: Create and refine user-friendly AI interfaces for clinicians, enabling effective application of AI-generated insights in patient care. - Rehabilitation Professionals: Leverage AI-enhanced feedback to craft adaptive rehabilitation strategies responsive to real-time biosignal analysis. - Biomedical Engineers: Innovate AI-driven biomechanical tools for the design of prosthetics, orthotics, and assistive devices. **Key Features:** - Portability: Designed for easy transport and quick setup in clinical or any other environment. - Real-Time Data Collection: Offers acquisition of highly synchronized multimodal data in a raw format for developing state of the art algorithms. - User-Friendly Interface: Simplifies operation for both technical and non-technical users, including engineers and healthcare personnel. - Comprehensive Reporting: Delivers detailed reports on gait characteristics such as stride length, speed, and balance for thorough clinical evaluations. - Expert Personnel: Specialists with extensive experience in analyzing gait and movement disorders, particularly those related to Parkinson's disease, to provide accurate assessments and insightful analysis for informed diagnoses and treatment planning. **Possible Applications:** - Algorithm Validation: Supplies precise and repeatable gait data essential for the evaluation of therapeutic interventions. - Multimodal Data Acquisition: Acquire medical grade data of various biosignals like ECG, EMG, motion or PPG (further sensor frontends in development). - Identify Relevant Modality: Identify the most relevant biosignal for your use case to acquire and use only relevant data in your application. - Fast Prototyping: Aside from your algorithm, you can validate your innovative wearable sensor technology and synchronize it to data from traditional sensor frontends. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Politecnico Di Milano (POLIMI)

To facilitate post-market surveillance implementation, as introduced by the MDR, this service offers pro-active information retrieval relevant to reported problems in medical devices by scanning and aggregating query results from official public databases of competent national authorities. Keywords: Post market surveillance, Risk analysis, Pro-active market vigilance, MDR, Field safety notice, PSUR

Politecnico Di Milano (POLIMI)

In order to contribute to pre-market evaluation for a certain new technology, risk assessment based on the search for reported problems for products of similar category already on the market will be provided by scanning and aggregating query results from official public databases of competent national authorities. In addition, relevant manufacturers information to determine the actual market share will be also provided. Keywords: Risk analysis, Pre-market evaluation, New technology

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Support in setting up a privacy-preserving architecture (Secure Platform for Medical Data Analysis) on premise (local private cloud) when anonymisation/ pseudonymisation cannot be guaranteed due to the dataset or processing characteristics. Supports various privacy preserving techniques (federated learning, split learning, …) and especially for multicentric approaches. Method Description: Support to install a secure architecture for multicentric analysis of medical data with a complete federated model execution environment if needed. Depending of the use case, we can propose: * Design of cloud architecture * Design of federated learning architecture * Aggregator optimisation in federated learning * Enhanced security : to secure the model shared between the partner in the coalition. ** Full Homomorphic Encryption (FHE) : perform operations on encrypted data without having to decrypt it. ** Secure Multi-party Computation (SMPC) : enables several parties to work together to perform calculations on shared data without revealing the underlying information. ** Differential Privacy (DP) : Addition of Guissian noise in data to reinforce the protection of privacy. Method reference: https://www.mdpi.com/1424-8220/22/2/450 https://www.sciencedirect.com/science/article/abs/pii/S0020025518308338 https://www.intechopen.com/chapters/45421 https://ercim-news.ercim.eu/en126/special/inah-the-ethical-secure-platform-for-medical-data-analysis

Politecnico Di Milano (POLIMI)

We offer a methodological approach to support SMEs/start-ups in the early development stages of a surgical robotic solution. We provide expertise in methodological approaches in the field of medical robotics. https://journals.sagepub.com/doi/full/10.1177/1729881419865805 Keywords: Requirement Elicitation Studies, Medical Robotics

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Development of PoCs (Proof of Concepts) or demonstrators involving data collection from distributed and heterogeneous data sources (IoT sensors, devices, APIs, etc.) based on lightweight but yet flexible and evolvable middleware architecture leveraging data modeling and data semantics. This service is customised to the customer need and PoCs can cover one, part or all of the following : IoT (wireless) protocols interfacing, gateway integration and programming, implementation of data processing, transformation and transmission to remote platforms. PoCs leverage DMWay toolbox where relevant ( https://asset.cetic.be/en/dmway/) Keywords: IoT, medical devices, wireless communication,firmware, middleware, PoC , prototype, gateway

Karolinska Institutet (KI)

The Swedish node is a collaboration between Karolinska Institutet, SciLifeLab and RISE. Together, we offer world-leading services with our unique collection of core facilities. We can grant services in expert consulting, virtual- and physical testing in the range of in vivo imaging, ex vivo OMICS, pharmaceutical development, simulated healthcare environments, AI-system validation and development, advanced data analysis and other data-driven life science. Prospective data set collection: A full-service collection of new data sets. This service serves to create data sets on-demand according to the needs and requirements of the SME for TEF-project purposes, such as validation. Data sets will primarily comprise in vivo imaging data (PET, CT, MRI, MEG, EEG), ex vivo imaging, and OMICS data within neuro and cancer. Data can be generated by CIR and SciLifeLab infrastructures within our “Physical Testing” services or assembled from publicly available databases and research collaborations. We provide expertise and technical support in the following areas: o Project design& management o Ethical application support o Data collection o Data assembly o Data cleaning, annotation, anonymisation This service can typically directly collaborate with “physical testing services” and technology infrastructures to generate raw data material.

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Overview This service provides access to a Pulse Wave Cartography Laboratory dedicated to the mapping of human cardiovascular signals. The facility captures pulse-wave data by synchronizing non-contact radar with contact sensors. The laboratory includes a custom two-axis measurement setup that allows a radar node to move above a participant, recording skin-surface micro-movements caused by the cardiac cycle. By combining these non-contact spatial measurements with simultaneous electrocardiogram and impedance cardiography data, the service provides structured datasets for cardiovascular research and device evaluation. How can the service help you? This service assists in validating cardiovascular monitoring technologies, such as non-contact sleep monitors or wearable sensors, against standard clinical signals. It addresses the requirement for mapped, synchronized ground-truth data. The service outputs synchronized, multi-axis datasets that correlate experimental sensor data with established reference signals, providing empirical data for device verification and algorithm training. How will the service be delivered? The service is performed in the biomedical engineering laboratory in Erlangen, Germany. A typical data collection session involves participants in a resting supine position while the two-axis radar system is maneuvered above them. The laboratory staff manages the hardware setup, the positioning of the radar node, and the synchronization. Upon completion, clients receive the aligned dataset. Additional information Provider description Our team has deep expertise in automated movement analysis, multimodal behavioral tracking, and complex data synchronization. With advanced facilities dedicated to biomedical engineering and affective computing, we offer SMEs expert guidance and state-of-the-art testing environments to develop, validate, and certify AI-driven healthcare solutions and wearable technologies. Technical details The laboratory acquires synchronized pulse wave dynamics using electrical, optical, acoustic, and electromagnetic sensors. Reference Signal Acquisition: Physiological monitoring is performed using a BIOPAC MP36 system, capturing Electrocardiogram (ECG), Impedance Cardiography (ICG), Photoplethysmography (PPG), and Phonocardiography (PCG). Non-Contact Spatial Mapping: The setup includes a 61 GHz continuous-wave radar node (EmRad system, Technical University of Hamburg; Albrecht et al., 2024). It is mounted on a two-axis mechanical measurement setup for the spatial tracking of cardiac micro-vibrations across the participant's body surface. Auxiliary Measurements: A body scale is available for biometric profiling, including body fat percentage and body composition metrics. Software & Synchronization: Data acquisition and temporal alignment are managed through Biopac Acqknowledge and the EmRad software. Service customization The service can be adapted to specific technical requirements. The spatial trajectory, scanning speed, and measurement points of the two-axis radar system can be customized based on the specified region of interest (e.g., focusing on the thoracic cavity or peripheral arterial sites). The reference signals can also be selectively applied; clients may opt to use only the ECG and PPG sensors if ICG and PCG are not required for their study.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Assessment of the architectural quality of AI software. The service offers a high-level assessment of the quality factors in AI-based software architecture, from design to implementation, using CETIC's "Archicheck" methodology. The assessment is based on ISO25000 and provides scores for each criterion, as well as an overall score for architectural design quality. The assessment offers a quick, high-level overview of the quality of an application's architecture and pragmatic recommendations for rapidly improving problem areas. Keywords: quality development

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Providing expertise and recommendations on analysing biases in the dataset or between datasets that could influence the performance of the algorithm. Differences could, for example, be caused by measurement devices or the operator. Method Description: For unknown biases can be tested with, for example, clustering algorithms or layer-wise relevance propagation for supervised learning. Method reference:

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Providing expertise and recommendations on the handling and standardization of data. Method Description: Individual recommendations for data storage and retrival, considerations regarding usage of datasets in ML Method reference:

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Providing expertise and recommendations on how to test and how to evaluate AI systems with respect to explainability, robustness, and performance. Method Description: Method reference: e.g. https://doi.org/10.1007/s10489-023-04532-5

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Biological evaluation is a critical process in the development of medical devices, aimed at assessing their safety and biocompatibility when interacting with biological systems. This evaluation ensures that the materials used do not cause adverse biological responses, and is guided by the ISO 10993 family of standards. To systematically address these requirements, it is essential to develop a Biological Evaluation Plan (BEP), detailing the specific tests and assessments needed based on the device’s intended use, material composition, and duration of contact with the body. The findings from this process are compiled into a Biological Evaluation Report (BER), which summarizes the results, demonstrates compliance with ISO 10993, and ensures the device’s safety and regulatory approval.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Compliance with MDR requires a robust Clinical Evaluation to demonstrate the safety, performance, and clinical benefits of a medical device. This process involves a systematic assessment of clinical data related to the device. In the context of Clinical Evaluation, IPN services include: - Development of a Clinical Evaluation Plan (CEP): Defining the scope, methodology, and objectives of the evaluation, tailored to the device and its intended use. - Identification and Appraisal of Clinical Data: Systematic collection, appraisal, and analysis of clinical data from existing literature, clinical investigations, and post-market sources. - Elaboration of the Clinical Evaluation Report (CER): Compilation of all findings into a detailed CER aligned with MDR requirements to support regulatory submissions. - Gap Analysis: Evaluation of existing clinical data to identify gaps and strategies to address deficiencies, ensuring compliance with regulatory standards. This service ensures a systematic and compliant approach to clinical evaluation, supporting regulatory approval and lifecycle management of medical devices.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The placing of a medical device or an IVDon the market is preceded by an evaluation of the residual risks related to quality, safety and performance. However, this evaluation shall continue throughout the entire lifecycle of the device, including the post-market period. Post-market surveillance allows manufacturers to collect and analyze experiences of the actual use of medical devices. Based on the outcome of this analysis, further actions such as incident reporting to competent authorities, field safety corrective actions or safety warnings to users may be required. Post-market surveillance activities are planned in the Post-market Surveillance Plan and the data is compiled in the Post-marketing Surveillance Report - PMSR (for class I medical devices) or the Periodic Safety Update Report (for class IIa, IIb and III medical devices or class C or D IVDs). Our unit assists in the elaboration of the PMS Plan with the definition of actions and also the elaboration of PMSR or PSUR

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN provides expert guidance in identifying the applicable pre-clinical tests required for medical devices, ensuring alignment with regulatory standards and facilitating a seamless pathway to market. The focus is on determining the specific tests based on the unique characteristics of the device, such as whether it is sterile, active, implantable, or software-based. Examples of pre-clinical tests include electrical safety and electromagnetic compatibility (EMC) evaluations, biocompatibility assessments (e.g., cytotoxicity, sensitization, and irritation testing), cybersecurity analysis, sterilization and cleaning validation, microbiological tests (e.g., bioburden and sterility), and stability or shelf-life studies. Additionally, IPN’s team assist in identifying accredited laboratories with proven expertise to conduct these tests, guaranteeing reliable and regulatory-compliant results.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The IPN team conducts thorough audits of Quality Management Systems (QMS) to ensure compliance with key regulatory requirements, including ISO 13485, FDA’s 21 CFR Part 820, and the European MDR and IVDR regulations. Independent auditors perform on-site or remote assessments to evaluate the effectiveness and conformity of the QMS, supporting both initial certification audits and ongoing surveillance or recertification audits.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

According to Article 15 of the MDR, the manufacturer of medical devices is required to have, within its organization (or an external person for small companies), a person who is responsible for regulatory compliance and with the explicit responsibility to ensure that all 'Manufacturer's Obligations' are met (Article 10). Our team includes competent and experienced people to play the role of Person Responsible for Regulatory Compliance, ensuring: - The verification of the conformity of medical devices according to the QMS (Article 10(9), MDR); - Maintenance and updating of technical documentation (Article 10(4) and (6), MDR); - Compliance with market surveillance obligations (Article 10(10), MDR); - Fulfilling incident reporting obligations (Article 10(13), MDR).

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN performs gap analysis, in order to assist the success of MD or IVD development projects, with the ultimate goal of making the devices available in the intended markets. This analysis identifies data gaps in projects, procedures, and product regulatory roadmaps, considering the regulatory requirements. The regulatory/market assessment gap analysis consists, among others, of the following steps: map out current policies and procedures; outline the regulatory and normative framework and determine which requirements the organization and/or project needs to meet; identify and analyze the gaps; establish concrete recommendations on how to resolve the gaps.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Risk evaluation gap analyses are designed to assess the potential risks and vulnerabilities associated with medical devices or IVDs. The IPN team assists companies by conducting comprehensive gap analyses of current risk identification and evaluation processes for their devices, identifying any shortcomings in the existing risk management framework. Leveraging the principles outlined in ISO 14971, the team evaluates the adequacy of risk management practices and ensures compliance with international standards. Based on this initial evaluation, the team can also support the development of an action plan to mitigate or eliminate identified risks effectively.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN includes qualified trainers who provide specialized training in the area of medical device regulation, with our greatest experience being in Regulation (EU) 2017/745, Regulation (EU) 2017/746, Risk Management (according to ISO 14971), Quality Management Systems (according to ISO 13485) and Performance and Clinical Evaluation. All trainings are accredited and can be in a face to face or online mode, divided into asynchronous sessions and synchronous sessions. In addition to specialized training and mentoring services, we also offer free webinars on the topics mentioned above.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The MDR and IVDR states in Article 10 (9), the requirements for the Manufacturer’s QMS. Despite not being specified, ISO 13485 is the most suitable quality management systems standard for medical devices companies. In the US, manufacturers must comply with the FDA’s Quality System Regulation (21 CFR Part 820), which outlines similar requirements for design, production, and process controls. The IPN helps medical device and IVD companies implement their QMS in compliance with the applicable regulatory framework. So, in order to meet the requirements and also operators’ specific needs, IPN team work closely with each section or department representatives.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

The European database on medical devices (EUDAMED) improves transparency and coordination of information regarding medical devices available in the European market. The database consists of 6 modules, and IPN can assist organizations in using the modules already available, that is, in the registration of manufacturers, importers, and authorized representatives in the "Actor Registration Module" with the issue of the “Single Registration Number” (SRN), and in the device registration in the “UDI/Device Registration Module”

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN team is able to bridge the gap between companies and the Notified Bodies. More specifically, the team supports the management of communication with the Notified Bodies during the certification submission process. This support includes guidance and support for the Notified Body selection according to the applicable product codes, assistance in requesting quotes, filling in the form, Gap analysis of the TD prior to submission and support in responses to Notified Bodies’ requests for additional information about submissions.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

With special focus on active devices, IPN supports manufacturers, distributors, and importers of MDs and IVDs, in the CE marking process taking into account the applicable requirements of Regulation (EU) 2017/745 (Medical Device Regulation - MDR) or Regulation (EU) 2017/746 (In Vitro diagnostic Medical Device Regulation – IVDR), as applicable. In this context, IPN supports the implementation and review of the Quality Management System (QMS), together with the elaboration or revision of the Technical Documentation (TD) of the device (under Annex II and Annex III of MDR or IVDR). IPN also support the company, depending on the device class, with the submission of the certification request to a notified body.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN provides services related to the Unique Device Identification (UDI) system, which ensures proper traceability of the devices throughout the distribution chain and by the user. IPN assists in the registration of organizations within an accredited UDI issuing agency, in the creation and correct use of UDI codes (UDI-DI, UDI-PI and basic UDI), ensuring that UDI data is formatted correctly for submission to EUDAMED and/or Global Unique Device Identification Database (GUDID – FDA). IPN also provides support in the maintenance of data related to the UDI.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Vigilance means to be watchful of the possible danger or difficulties. The medical device Vigilance System is designed to collect information on post-market incidents or adverse events related to medical devices and, where appropriate, distribute or disseminate such information to prevent adverse events from recurring. This indicates that medical device manufacturers must have a dedicated system in place for the management of vigilance activities. It is the manufacturers or, if applicable, the European Authorized Representatives’ obligation to notify the Competent Authority in case of any incident with their devices. In the regulatory unit, we help manufacturers to implement medical device Vigilance Systems in compliance with all legal and regulatory requirements and also support incident reporting as well as incident investigation and further actions implementation.

RISE Research Institutes Of Sweden

RISE Cyber Range is a secure and realistic training and testing environment. The service also includes controlled penetration testing. Organizations can use the environment to practice and evaluate their ability to prevent, detect, and manage cyberattacks. The service is designed to be understandable even for non-technical decision-makers. It provides a clear picture of an organization’s cybersecurity maturity. RISE Cyber Range uses highly realistic IT and OT environments. These environments are used to identify technical vulnerabilities through penetration testing. They are also used to improve incident response capabilities. The service strengthens collaboration between technical teams, management, and business functions. How can the service help you? The service helps organizations to: - Perform penetration testing - Train staff using realistic cyber incident scenarios - Test technical safeguards and processes in a safe environment - Evaluate organizational readiness and decision-making under pressure - Identify improvement areas before real incidents occur How the service will be delivered Logistics: The Cyber Range environment is provided by RISE and can be delivered on-site, remotely, or as a hybrid solution depending on customer needs. Delivery period: Delivery is planned in close cooperation with the customer and can be conducted as a single engagement or as a series of recurring exercises over time. Duration: The duration of the exercises ranges from a few hours to several days, depending on the scenario and desired level of depth. Customer requirement: The customer is expected to provide high-level information about their organization, relevant threat scenarios, and participants for the exercise. Deliveries: RISE delivers a fully configured cyber range environment, scenario-driven attacks, facilitation, and technical and methodological support throughout the engagement. Output: After completion of the service, the customer receives structured feedback in the form of observations, analysis, and recommendations. Service customization The service can be customized to meet the customer's specific needs, technical environment and level of maturity in cybersecurity. The assessment process begins with a joint meeting where the customer and a technical team from RISE discuss different options and tailor a service that is designed based on the customer's needs.

Univerzita Komenskeho V Bratislave (UK BA)

The laboratory provides detection of RNA expression in low, medium and high throughput screening methods, including real-time PCR or microarray (MA). In additon, it provides detection of miRNA expression in low, as well as in high throughput screening meethods, including real-time PCR (qPCR) or microarray (MA). The service includes insight into technology, sample preparation, and partial or full bioinformatic data processing.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Robotics Companies: For testing and validating social robots and speech-enabled systems in realistic clinical environments before market entry. - AI & NLP Developers: For evaluating natural language interfaces on physical robotic platforms in real healthcare workflows. - Healthcare Institutions: For assessing how robotic systems perform in their specific clinical contexts before committing to procurement. - Research Groups: For conducting HRI studies in controlled yet realistic hospital settings with access to clinical staff and infrastructure. **Equipment / Robotics Platforms:** - SoftBank Robotics Pepper humanoid social robot designed for increased engagement with the patient via expressive upper body mechanics. - Temi mobile service robot designed for telepresence, guidance, and information delivery as well as conversational interactions. **Key Features:** - Access to a dedicated Real-Lab (Reallabor) providing hardware and clinical test environments for evaluating robotic systems in healthcare settings - Testing of NLP/speech-enabled robots in realistic clinical workflows with actual healthcare personnel - Evaluation infrastructure for both controlled laboratory experiments and in-situ ward-level assessments - Multi-disciplinary support combining robotics engineering, clinical expertise, and social science perspectives **Possible Applications:** - Ward Assistant Robot Testing: Evaluating mobile robots designed to support nursing staff with logistics, information delivery, or patient guidance in realistic hospital corridors and wards. - Speech Interface Validation: Testing natural language dialogue systems on robotic platforms in noisy, dynamic clinical environments to assess robustness and usability. - Staff Relief Assessment: Quantifying the cognitive, physical, and time-based relief potential of robotic systems for medical personnel through structured pilot studies. - Patient Interaction Evaluation: Assessing how patients (across age groups, health conditions, and tech literacy) respond to and interact with social robots in clinical settings. - Workflow Integration Testing: Evaluating how robotic systems integrate into existing clinical workflows without disruption, including edge cases and failure scenarios. - Multi-Robot Coordination: Testing multiple robotic systems operating simultaneously in shared clinical spaces. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Centre Hospitalier Universitaire De Rennes (CHU RENNES)

Scanner (Canon & Siemens), imaging, data acquisition, clinical

HUMANI SC - Hospital network (HUMANI)

Design and writing of communication support in compliance with editorial and scientific guidelines for publication (journals, meetings, events...).

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Clinical Researchers: For strengthening study designs and hypotheses with a comprehensive understanding of existing literature. - Medical Product Developers: To advance the development of innovative medical solutions by integrating scientific research insights. - Academics and Healthcare Professionals: For engaging in scholarly dissemination of research, raising the profile and recognition of their work. **Key Features:** - Systematic Literature Research: Conducts comprehensive, literature searches to establish the scientific foundation for clinical investigation plans, regulatory submissions, and product positioning. - Clinical Investigation Plan (CIP) Development: Authors complete, ISO 14155-compliant study plans including objectives, design, endpoints, visit schedules, and statistical considerations. - Data Management Planning: Develops detailed DMPs covering database design, data collection procedures, validation rules, coding dictionaries, and quality assurance workflows. - Biostatistical Analysis: Provides full statistical support from sample size calculation and analysis plan development through to confirmatory analysis, subgroup evaluations, and results interpretation. - Clinical Investigation Report (CIR): Produces comprehensive final study reports documenting methods, results, and conclusions in accordance with ISO 14155 and regulatory expectations. - Scientific Dissemination & Publication: Supports or leads the preparation of peer-reviewed manuscripts, conference abstracts, and strategic dissemination planning. - Product Development Guidance: Translates scientific evidence into actionable recommendations for medical product design, differentiation, and clinical positioning. **Possible Applications:** - MDR Clinical Evaluation Support: Conducting systematic literature reviews and writing clinical evaluation reports (CER) to fulfill MDR Annex XIV requirements for medical device certification. - Planning Investigator-Initiated Trials: Developing robust CIPs and DMPs for academic research groups conducting clinical studies on novel sensor technologies or digital health solutions. - Regulatory Submission Documentation: Producing the complete documentation package (CIP, SAP, DMP, CIR) required for notified body review or competent authority submissions. - Biostatistical Consulting for MedTech Startups: Providing sample size calculations, endpoint selection guidance, and analysis strategies for companies designing their first clinical study. - Multi-Center Study Coordination: Harmonizing documentation, data management, and statistical reporting across multiple investigational sites. - Scientific Visibility for Industry Partners: Transforming proprietary study results into high-impact publications, raising the scientific profile of commercial innovations. - Grant Proposal Support: Strengthening research funding applications with solid literature foundations, well-designed study concepts, and credible statistical frameworks. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Zilinska Univerzita V Ziline (UNIZA)

Consulting and development of serious games using Unity for healthcare, training, and educational applications. These interactive tools are designed to engage users while collecting valuable insights, supporting behavior change, or improving clinical and learning outcomes across multiple platforms including VR and AR. Technical details:Developed in Unity; supports WebGL, Android, Windows, VR/AR platforms. Use cases/examples: An SME with an AI system wants to develop an interactive and immersive training application. This application can be deployed as a virtual reality, server-client or standalone PC application.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Hospital processes optinisation. CETIC offers its expertise in the field of data management, process simulation, and other innovative expertise that could best optimize the multiple flows related to processes in a hospital, such as the sterilization process. The idea is to build a simulation model of the centralized shared sterilization process based on existing data from several hospitals in order to test and optimize the sizing of the future process. How can the service help you? This service provides a simulation service of sterilization facilities, to evaluate the sizing and robustness of such facilities against the expected flow of trays to sterilize. How the service will be delivered? The service will be delivered by first collecting relevant input data, which includes the medical tool documentation (detailing the description of medical tool sets exported from the sterilization software) and activity data (providing traceability of the passage of sets within the sterilization department). Additionally, data representing the sterilization facility and its environment, such as transportation logistics (e.g., by trucks if applicable), will be gathered. Once the input data is collected, a series of scenarios will be simulated to assess the performance and capacity of the sterilization facility. These simulations will validate investment decisions by providing key performance indicators, including the occupancy rate and overall performance of the facility under various operating conditions. Method reference: Discrete event simulation

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Rental of the Simulation rooms, audio and video recording. Cameras, projectors for 4 sides; Acciden site simulation. "From home to hospital" Simulated hospital. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Rental of the Simulation rooms, audio and video recording. Cameras, projectors for 4 sides. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting research, analysis. User testing. "From home to hospital" Simulated hospital.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

"From home to hospital", Simulated hospital. Rental of the Simulation rooms, audio and video recording. Pre-clinical testing: Helping with research questions (user, customer experience, etc.) Testing the situation as genuinely as possible (Organising skills to create a genuine situation). Helping with the research design and conducting the research, analysis. User testing.

Hospices Civils De Lyon (HCL)

Rental of the surgical facility (130m²), including: - a simulated operating room, with audio-video recording of testing sessions - an observation room with audio-video controls - a meeting room for debriefing, focus group , etc. - a convivial space to welcome participants

Multitel (MULTITEL)

EMC Testing for product development and pre-certification for radiated emission and immunity (EMC, radiated emission and immunity). This service will be deliver in the Multitel anechoïc chamber located in Mons (Belgium). The device under test could reach 1,5 m diameter and 1 ton weight. For both radiated emission and immunity, we cover standard for classical device industrial, scientific and medical and large consumer electronic device (CISPR11/CISPR32/EN 61000-4-3). Others standard for specific domain (spatial, military, avionics, automotive, railway) can be covered by Multitel equipment. ETSI communication tests are mandatory for wireless device (Bluetooth, Wifi, Nb-IOT, xG, ..). For these wireless devices, commercial modem are usually used. These modems are itself certified but with a restricted way of used (antenna for example). So ETSI tests has to be passed with the full device. Arguing modem certified to justify device certification is not fully relevant. Multitel provides ETSI pre-tests also (ETSI, wireless, communication test, CE marking).

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Overview This service provides sleep monitoring and analysis utilizing a combination of medical-grade clinical equipment and non-contact sensing technology in a controlled sleep laboratory environment. The facility is centered around a hospital bed equipped with a full-scale polysomnography (PSG) system to collect electroencephalography (EEG), electrocardiography (ECG), photoplethysmography (PPG), electromyography (EMG), respiration, and motion data. Simultaneously, an array of high-frequency radar sensors installed beneath the mattress records cardiorespiratory micro-movements, while a night-vision camera tracks facial expressions and body posture during sleep. The aim of the service is to provide synchronized reference data and non-contact measurements for sleep staging, detection of sleep disorders (such as sleep apnea, snoring, and restless limb movement), and the evaluation of sleep-monitoring systems. How can the service help you? Developing and testing sleep-monitoring devices, mattress sensors, or contactless algorithm models requires validated, full-night clinical reference data. This service solves the challenge of obtaining simultaneous clinical polysomnography and experimental non-contact radar data. Clients without access to a specialized sleep lab receive synchronized datasets containing ground-truth PSG sleep staging alongside contactless radar signals and night-vision video. This allows companies to train sleep-staging algorithms, validate contactless heart rate and respiration tracking, and test non-wearable sleep diagnostic solutions against medical-grade standards. How will the service be delivered? The service is offered in person at the sleep analysis laboratory in Erlangen, Germany. Overnight recording sessions are organized in accordance with standard sleep study protocols. Laboratory staff manage participant onboarding, PSG electrode placement, sensor setup beneath the mattress, and camera alignment. Following the recording session, data are processed, synchronized, and delivered to the client, along with standard PSG sleep-staging reports. Provider description Operating from the Department of Artificial Intelligence in Biomedical Engineering at Friedrich-Alexander-Universität Erlangen-Nürnberg, we are a service provider node within the TEF-Health consortium. The research group specializes in machine learning, biomedical signal processing, and multimodal sensor synchronization. Our team provides testing infrastructure and scientific support for evaluating medical devices, wearables, and contactless sensing systems. Technical details: The laboratory utilizes a hospital bed environment integrated with multiple synchronized measurement modalities: 1. Polysomnography (PSG): A Somnomedics PSG system serves as the clinical reference, recording EEG, ECG, PPG, EMG (muscle activity), respiration, accelerometry, and ambient sound via microphones for sleep staging and sleep disorder assessment (e.g., sleep apnea, restless legs/arms). 2. Non-Contact Radar Array: A multi-node array of 61 GHz continuous-wave radar units (EmRad system, Technical University Hamburg; Albrecht et al., 2024) is positioned beneath the bed mattress to measure heart rate, respiratory effort, and body movements without direct skin contact. 3. Visual Recording: A night-vision camera is mounted to enable facial expression analysis and posture tracking during low-light and dark overnight conditions. 4. Software: Data acquisition, signal filtering, and clinical sleep staging are executed using Somnomedics Analyze alongside custom signal-processing scripts for radar data extraction. Service customization: The study configuration can be customized based on specific research objectives. Clients can opt to utilize the full PSG array for comprehensive clinical validation or select a subset of sensors (e.g., respiration and ECG channels only) to adjust setup duration. Sensor placement, radar array density, and video resolution can be configured according to project specifications.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Who Can Benefit:** - Clinical Researchers and Study Designers: For leveraging AI capabilities to refine and finalize study protocols, enhancing their effectiveness and feasibility. - Medical Product Developers: To assess the clinical viability of new products and solutions, ensuring they meet necessary evaluation criteria before market introduction. - Research and Development Teams: For innovative project development utilizing cutting-edge AI technologies to optimize research outcomes. **Key Features:** - AI-Driven Protocol Parsing: Leverages artificial intelligence to automatically parse, structure, and analyze clinical study protocols, extracting key parameters and identifying inconsistencies or gaps. - Feasibility Assessment: Conducts detailed evaluations to determine the viability of clinical studies for medical products, ensuring alignment with research goals and regulatory standards. - Design Optimization Recommendations: Generates actionable suggestions for protocol refinement – from endpoint selection and visit schedules to sample size considerations and risk mitigation. - Regulatory Alignment Check: Automatically flags protocol elements that may conflict with applicable standards (ISO 14155, MDR, ICH-GCP) or require additional justification. - Expert-in-the-Loop Guidance: Combines AI-generated insights with human expert review from clinical and technical specialists to deliver validated, trustworthy recommendations. **Applications:** - Study Protocol Evaluation: Employs AI technologies to enhance the accuracy and efficiency of protocol assessments, identifying potential challenges or areas for improvement. - Clinical Feasibility Analysis: Provides critical insights into the practicality of proposed research projects, aiding in the decision-making process for medical product development. - AI-Enhanced Clinical Research: Supports the integration of AI tools to streamline clinical study planning and execution. **Who we are:** The **Fraunhofer IIS** has established the **"Center for Sensor Technology and Digital Medicine"** in cooperation with the University Hospital Erlangen and the University of Erlangen-Nuremberg to enhance healthcare efficiency through **sensors** and **digital solutions**. This center focuses on integrating **innovative medical technologies** like **patient-specific therapies**, **digital health applications**, **medical diagnostics** via **wearables**, and **robotic systems** for care. Located at the University Hospital Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Providing an Open Source software framework to simplify the comparison of ML and traditional algorithms Method Description: A generic way to build object-oriented datasets and algorithm pipelines and tools to evaluate them. Method reference: https://github.com/mad-lab-fau/tpcp

Commissariat A L Energie Atomique Et Aux Energies Alternatives (CEA)

This service provides 2 types of analysis: - Ex vivo imaging study : Multiplex spatial distribution of molecular species in biological tissue - Profiling study: multiplex analysis in complex biological samples. It includes: - Project design & feasibility study - Sample conservation, preparation and analysis using softwares such as Fleximaging & Flexcontrol - Data analysis with provision of a final report Examples: Evaluate or Compare AI system of an IVD-MD to mass spectrometric (MALDI) data of specific animal/human tissue Keywords: Mass Spectrometry; MALDI; ex vivo imaging study; profiling study

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

Overview This service offers a comprehensive, fully equipped laboratory environment for reliably inducing and measuring acute psychosocial stress. By utilizing standardized protocols, we capture a wide array of human responses through a multimodal approach. Our capabilities include full-body motion capture, high-resolution posturography, and video-based facial and behavioral analysis to extract accurate digital biomarkers. Furthermore, we provide continuous physiological monitoring alongside the systematic collection of biological specimens for biopsychological marker analysis. This integrated service allows startups and SMEs to thoroughly evaluate stress-related interventions, health-tech wearables, or AI-driven behavioral models in a highly controlled, standardized, and scientific setting. How can the service help you? For companies developing health-tech wearables, digital therapeutics, or AI algorithms aimed at stress monitoring, gathering high-quality, ground-truth data is a significant hurdle. This service solves that problem by providing a validated, end-to-end pipeline for stress induction and measurement. By utilizing our laboratory, you receive biological, physiological, and biomechanical datasets. This enables you to accurately train predictive models—such as those that detect behavioral indicators of stress—validate the accuracy of hardware sensors, and confidently demonstrate the clinical efficacy of your technologies. How will the service be delivered? The service is delivered physically at our specialized Stress Induction Laboratory facilities. Execution time varies depending on the cohort size and the specific combination of measurement modalities requested, but a standard stress-induction protocol requires a dedicated session per participant. Our team coordinates the entire technical setup of all recording equipment (including cameras, microphones, and biometric sensors) and manages the collection of biological specimens. Customers receive the processed, synchronized, and annotated datasets securely after the experimental phase is concluded. Additional information Provider description We are a service provider node within the TEF-Health consortium, specializing in artificial intelligence, machine learning, and digital health innovations. Our team possesses deep expertise in automated movement analysis, 3D human pose estimation, and complex multimodal data synchronization. With advanced facilities dedicated to biomechanics and behavioral tracking, we offer SMEs guidance and state-of-the-art testing environments to develop, validate, and certify AI-driven healthcare solutions and wearable technologies. Technical details The core of the service relies on two standardized rooms tailored for stress testing, ensuring the gold standard for inducing acute psychosocial stress. Behavioral & Motion Tracking: We utilize 2 RGB cameras for multi-angle facial expression and body movement analysis, complemented by a wireless microphone for audio feature extraction. Precise biomechanical profiling is achieved using an XSens inertial sensor-based motion capture system alongside a Zebris FDM 1.5 posturography system for pressure distribution. Physiological & Biological Measurement: Continuous physiological monitoring is conducted using a Biopac MP160 system (tracking ECG, ICG, and respiration) and a Calera body core temperature sensor. Specimen Collection: The laboratory facilitates the standardized collection and storage of saliva samples and dried blood spots, processed in strict accordance with Bio S2 laboratory standards. Software Integration: Post-processing and data alignment utilize specialized, industry-standard software including Biopac AcqKnowledge, XSens MVN Analyze, and Zebris Analysis Software. Service customization The service is highly modular and can be customized to match your specific research or product development goals. While we can provide the foundational stress-induction framework, the measurement modalities are entirely flexible. An SME can opt for a purely non-invasive digital biomarker approach (e.g., utilizing only the RGB cameras and IMU sensors for behavioral tracking) or incorporate the full suite of physiological and biological sampling. We can also adjust camera placements, video resolutions, and labeling criteria to align with specific AI model training requirements. List of Services: - Full-body motion analysis using inertial motion capture, including posturography and pressure distribution - Video-based motion and facial expression analysis - Standardized and reliable gold standard stress induction - Collection of established biopsychological stress markers for further processing - Assessment and analysis of digital biomarkers during stress - Physiological measurements

Hospices Civils De Lyon (HCL)

Summative evaluation of finalized surgical robot prototype (design freeze) in order to validate usability (according to IEC 62366-1). This packaged service includes : - Operating room rental - Participants (healthcare professionals) recruitment within our hospital - Protocol elaboration - User testing organization and moderation - Analysis of collected data from a human factors perspective - Evaluation report including root causes analysis of errors, close calls and use difficulties observed Prices range is indicative and depends on testing protocol complexity and particpants number

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

Annex XV of the MDR outlines the requirements for the documentation regarding the application for Clinical Investigations to be conducted within the European Union. Similarly, Annexes XIII and XIV of the IVDR outlines the requirements for the documentation regarding applications for clinical performance studies and other performance studies . IPN is able to provide support in a two-step approach, • Study Documents & Submission Process, supporting the preparation of the mandatory documents and the submission of study to the Regulatory Authorities (ethics committees and competent authorities). In this context, IPN services include: -> Clinical Investigation Plans (CIPs) / Clinical Performance Study Plan (CPSP) -> Investigator’s Brochure (IB) -> Case Report Form (CRF) -> Informed Consent Form (ICF) -> Clinical Investigation Report (CIR) / Clinical Performance Study Report (CPSR) and Supporting Documentation -> Additional specific forms for local ethics committees and Competent Authorities in different countries. • Study Monitoring & Data Management, supporting the Site Initiation activities, recruitment process, monitoring, data collection/analysis and CIR/CPSR according to ISO 14155:2020/ PSR according to ISO 20916:2019 - Good Clinical Practices/ Good Study Practices. If needed, Study Coordination support may also be made available.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Help to select and to use advanced deep learning algorithms to create custom and trustworthy AI models for medical image analysis (e.g. classification, segmentation, feature extraction, anomaly localization). Depending on the modality to be processed, we propose advanced deep learning architectures (CNN, LSTM, ViT, etc.) by selecting the best approach for the task to be performed (classification, localisation, segmentation, etc.). Keywords: Medical Image Analysis; Deep Learning Algorithms; Binary Classification; Anomaly Localization; AI Model Development; Real-World Images; AI Testing and Validation; Collaboration with Medical Staff; AI Expertise; Custom Pretrained Pipelines; Clinical Imaging; Image Segmentation; Image Feature Extraction; Trustworthy AI

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

Challenge : Difficulties in identifying the needs of users, clients, and other stakeholders, particularly regarding the development of AI-based products, to ensure a focus on the right challenges. This service provides support for the activities needed to collect and analyze requirements for the development of an AI-based product (software and hardware). In addition, the service offers support in setting up a technology roadmap with a prioritization of functionalities to be developed. Our strength: Guiding you in gathering requirements, analyzing needs, and technological guidance to steer future development by applying co-creation and co-innovation techniques with the assistance of a network of specialized stakeholders. Keywords: Business Analysis

Health Cluster Portugal - Associacao Do Polo De Competitividade Da Saude (HCP)

This service is designed to deliver valuable insights into emerging trends in healthcare innovation, tailored to support SMEs in their specific business areas. Keywords: Trends; Market; Technology

Politecnico Di Milano (POLIMI)

Testing of technical specifications and analysis of the outcome in a relevant environment (testing phase before real environment testing). Example: when applicable, tests with healthy users are performed to verify technical functions and usability, before moving to tests with the target population (patients). Keywords: Validation, Usability

Karolinska Institutet (KI)

Comprehensive assessment of healthcare AI startups and SMEs across four readiness dimensions—technical, regulatory, organisational, and market—delivering a prioritised roadmap to close identified gaps. The service includes: Technical Readiness Assessment Evaluation of AI model maturity, data pipeline robustness, validation status, deployment architecture, and scalability for clinical or production environments. Regulatory Readiness Assessment Review of compliance posture against the EU AI Act, MDR requirements, GDPR obligations, and status of ethical approvals. Organisational Readiness Assessment Assessment of team competencies, governance structures, quality management systems, and post-market surveillance capability. Market Readiness Assessment Review of product-market fit, go-to-market strategy, reimbursement pathways, value proposition clarity, and competitive positioning. Gap Analysis & Roadmap Structured mapping of gaps between current and target state across all dimensions, with prioritised recommendations, indicative timelines, and a follow-up session.

Politecnico Di Milano (POLIMI)

This service assesses algorithm performance, development progress, and adherence to AI Act regulations for implementation in clinical practice. The AI validation includes several aspects, aligned with TEF guidelines, and EU regulation: 1) Bias evaluation 2) Accuracy evaluation 3) Trustworthiness evaluation 4) Uncertainty evaluation. The validation will be offered on three levels, based on the source of the validation dataset: 1) End-user provides the data for validation (input features) 2) End-user provides data for validation at the start from raw data of the initial dataset (data curation and feature extraction on the validation set will be extracted by the Lab within the process of validation) 3) The POLIMI Lab provides a tailored external validation set acquired from other clinical centers. Keywords: Validation; Bias; Accuracy, Trustworthiness, Uncertainty, AI algorighm AI validation

Fondazione Istituto Italiano Di Tecnologia (IIT)

This service provides a complete testing setup for gait analysis, motion capture and IEC 10328 compliance for robotic exoskeletons and prostheses. It also provides support and recommendations about how to design and develop robotic rehabilitation systems compliant to IEC 60601-1 standard. Method Description: The service will perform an assessment of wearable robotics solutions (e.g. exoskeletons and prostheses) by using a combination of the following resources: VICON workstation with 12 cameras, sensorized treadmill, force platforms, surface electromyograph, metabolimeter. Method reference: Tests will be based on standards, most notably IEC 10328, when applicable. Otherwise, based on scientific methods for gait analysis. Keywords: robotics; healthcare robotics; prosthesis; orthosis; exoskeleton; testing setup.

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Service Keywords:** Expertise in Electrophysiological Signals, Cardiovascular Diseases, Multimodal Data Acquisition (ECG, EMG, EEG, EOG, EDA), Project Design, Clinical Study Design, Scientific-Technical Consulting, Data Evaluation, Data Acquisition, Technical Support, Performance Evaluation/Reporting **Equipment:** - Biosign HRV-Scanner Model II: Mobile blood pressure monitor for evaluating heart rate variability. - SomnoMedics Sleep Monitor: Measures EEG, ECG, BP, oximetry, IMU, and EMG for comprehensive sleep assessments. - Biopac System: Monitors ECG, respiration, oximetry, EEG, EMG, and skin temperature for detailed physiological recordings. - Wireless Biopac System: Offers the same capabilities in a mobile format for versatile monitoring. - Vinno G55: Provides advanced ultrasonic imaging for cardiac and vascular assessments. - Maphera: A multimodal, portable, wireless biomedical acquisition system for a variety of physiological data. - Custo Guard Holter with Custo Wing: Long-term ECG monitoring for in-depth cardiac analysis. **Who Can Benefit:** - Cardiologists: For conducting advanced diagnostic assessments and managing patient care through detailed cardiac and electrophysiological data. - Biomedical Researchers: To explore cardiovascular physiology and develop innovative treatments or technologies. - Healthcare Engineers: For designing and testing medical devices that integrate with cardiovascular monitoring technologies. - Clinicians and Healthcare Institutions: To enhance clinical services and research capabilities with comprehensive cardiac assessment tools. **Key Features:** - Comprehensive Cardiac Monitoring: Equipped with advanced systems to evaluate a wide range of cardiovascular and electrophysiological parameters, ensuring precise and detailed analysis. - State-of-the-Art Technology: Utilizes cutting-edge equipment for both mobile and in-lab assessments, supporting diverse clinical and research applications. - Expert Support: Offers extensive scientific and technical consulting, with expertise in electrophysiological signals, to guide project design and enhance study outcomes through high-quality data recording and analysis. **Possible Applications:** - Clinical Trials: Facilitates rigorous evaluation of new cardiac therapies and devices, providing essential data for regulatory submission and clinical validation. - Patient Monitoring: Enables continuous monitoring of cardiac health, improving early detection and intervention for arrhythmias and other cardiovascular conditions. - Research and Development: Supports the development of novel diagnostic and therapeutic solutions by providing a robust platform for electrophysiological data acquisition. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**Equipment:** - Gym Setup: Comprehensive facilities equipped for diverse sports and exercise testing. - Ergometer and Track: Standard equipment for controlled cardiovascular and endurance assessments. - BioPac System: Monitors ECG, respiration, oximetry, EEG, EMG, and skin temperature for thorough physiological analysis. - Wireless BioPac System: Offers mobile monitoring capabilities, ideal for field and in-lab scenarios. - Mobile ECG (Holter): Includes BTL Flexi 12, BTL Holter 08, and CardioSecure for continuous heart monitoring. - Smart Textiles: Integrates ECG and respiration monitoring directly into sportswear for seamless data collection. - XSens Cameras and Systems: Advanced biomechanical sensing with MVN Link, MVN Awinda 2, and pressure mapping for comprehensive motion capture and analysis. **Who Can Benefit:** - Sports Scientists and Researchers: For conducting advanced studies on human movement and optimizing athletic performance. - Athletic Trainers and Coaches: To design and refine training strategies based on precise biomechanical and physiological data. - Physical Therapists: To develop tailored rehabilitation programs and track recovery using comprehensive performance assessments. - Biomechanical Engineers: For developing sports-related technologies and equipment by leveraging biomechanical insights. - Professional and Amateur Athletes: To enhance performance and reduce the risk of injuries through data-driven insights. **Key Features:** - Multimodal Physical Activity Analysis: Specializes in comprehensive assessments of athletic performance using a wide range of physiological and biomechanical measurements. - State-of-the-Art Equipment: Provides versatile setups and advanced monitoring technologies to capture detailed data on physical activity and sports performance. - Expert Support: Offers robust scientific and technical consulting, featuring expertise in both electrophysiological signals and biomechanics, to optimize study design and data analysis. **Possible Applications:** - Athletic Performance Testing: Facilitates detailed analysis of athletes' physical abilities and limitations, supporting personalized training and rehabilitation programs. - Sports Science Research: Enables the study of biomechanics and physiology in sports settings, contributing to the development of innovative training methods and performance-enhancing techniques. - Injury Prevention and Rehabilitation: Assists in identifying risk factors and monitoring recovery progress, helping to minimize injury occurrence and expedite rehabilitation. - Neurological Disease Assessment: Identifying the severity of a Parkinsons disease from the gait of the patient. **Who We Are:** The **Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS)** has established the **"Center for Sensor Technology and Digital Medicine" (CEMDIS)** in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through **innovative sensor technology** and **digital solutions**. This center focuses on integrating **innovative medical technologies** such as **wearables** and **robotic systems** to support **medical diagnostics**, **patient monitoring** and **evaluating patient-specific therapies** by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the **development**, **integration**, and **validation** of novel health technologies, providing companies opportunities for **technological advancements**. For more information, visit the [Fraunhofer IIS website](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Fondazione Istituto Italiano Di Tecnologia (IIT)

This service provides a physical space (a multisensorial laboratory) that supports the testing and fast prototyping of multi-modal models deployments (images, text, other medical data) at different stages (dataset preparation, training, testing and evaluation). Such physical infrastructure provides a testing backbone to support small-scale proof of concept of large scale artificial intelligent architectures including the support from HPC infrastructures. Method Description: The service support SMEs in deploying multi-modal AI models related to their specific application scenario offering a physical intelligent environment that facilitates early prototyping and controlled testing . Method reference: Based on several state of the art architecture: Transformers, Diffusion Models, U-nets, and the most popular deep learning architectures.

Karolinska Institutet (KI)

The Unit: Clinical Genomics Stockholm (https://www.scilifelab.se/units/clinical-genomics-stockholm/) This infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Clinical Genomics Stockholm unit is a research infrastructure for large-scale, genomics-based analyses using next generation sequencing technologies. The unit assists in translational research projects, in the translation of genomics-based tools to routine clinical care and also aims to improve the capability for national microbial surveillance and for pandemic preparedness. The Service: Transcriptome sequencing (RNA-seq) Sequencing of mRNA (poly A based method) followed by fusion detection or germline analysis. This service encompasses: o Consultation (Project design, Target capture design) o Sample management o RNA sequencing (total RNA, mRNA) o Bioinformatics (Bioinformatic analysis on data generated at CG) Equipment Our unit has access to specialized equipment that enable us to factilitate the translation of new high-throughput techniques into clinical use. These include, but are not restricted to: • Various automatic robotic systems (BRAVO NGS Workstation, Hamilton NGS Star) • Various systems for QC, quantification and fragment analyses (TapeStation, Quantification using fluorescent assay (Qubit, Quantit)) • Instrumentation for real time PCR and ddPCR (BioRad qPCR) • Instrumentation for Multispectral imaging (Saphyr optical mapper) • Sequencing platforms: o Illumina (NovaSeq 6000, NovaSeq 6000 Dx, NovaSeq X) o Nanopore (PromethION “access via NGI”) o PacBio (Revio)

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Support iterative process of usability of the medical device prototype for CE mark. Includes the definition/revision of inputs for the usability specification according to the available documentation: - the intended use of the medical device - the risk analysis linked to usability - use scenarios Depending the SME needs, this service may be: - an expert evaluation by an ergonomist or; - support on protocol writing for formative evaluation. The proposed method is based on a user-centered procedure, as described in ISO 9241-210 on the ergonomics of human-system interaction, and complies with ISO 62366-1/ ISO 62366-2 on the usability of medical devices. Keywords: Usability test, Formative evaluation, Summative evaluation

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Formative evaluation of medical devices: user testing of any medical device prototype in order to improve usability (according to IEC 62366-1). It includes: - writing protocols depending user profiles. - recruitment of required healthcare professionals and patients - rental of the operating room if needed - rental of phantoms - one or several iterative user testing steps and result analyses - evaluation report including ergonomic corrections and guidelines to bring to the medical device

Centre Hospitalier Universitaire De Grenoble (CHUGA)

Summative evaluation of medical devices: final user testing of any medical device in order to carry out the final summative evaluation needed for CE mark (according to IEC 62366-1). It includes: - writing the protocol - recruitment of required healthcare professionals and patients - rental of the operating room if needed - rental of phantoms - user testing according the defined protocol and result analyses - evaluation report.

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

User interface evaluation is conducted with the intent to explore user interface design strengths, weaknesses, and unanticipated use errors. The usability testing focuses on the user experience with the device, including the device's graphical user interface (GUI). While a formative usability test goal is to identify and correct any usability problems before the device design is finalized, a summative usability testing intends to generate evidence that a final product that is not only functional but also intuitive and enjoyable to use, leading to increased user satisfaction and loyalty. IPN is able to provide support in a two-step approach: • Study Documents & Submission Process, supporting the preparation of the mandatory documents and the submission of study to the Regulatory Authorities (ethics committees); • Study Conduction & Data Management, supporting the Site Initiation activities, recruitment process, data collection/analysis according to good clinical practices and report

Instituto Pedro Nunes Associacao Para A Inovacao E Desenvolvimento Em Ciencia E Tecnologia (IPN)

IPN team is able to support the companies planning the iterative process where usability tests are carried out, finding the users and the usability scenario(s)/environment(s) and, if needed, the clinical researchers to conduct the testing in order to ensure that the solution usability is designed so that use-related risks are decreased, and safety increased.

Centro Hospitalar De Sao Joao Epe (CHSJ)

The service offers SMEs access to hospital workflows and infrastructure within a controlled, virtual environment. By simulatin a hospital setting, it assesses de the compatibility, interoperability and reliability of systems before deployment in real-world scenarios, reducing risk, saves resources and streamlines the integration proccess by identifying and resolving issues early in the development lifecycle.

Centre D'Excellence En Technologies De L'Information Et De La Communication (CETIC)

To enhance the security of software-based products, ensure compliance, and mitigate risks, CETIC offers expertise in scanning your system with automated tools to identify known vulnerabilities and potential weak points that attackers could exploit. This method involves the use of specialized software to identify security flaws, such as obsolete software versions, incorrect configurations or unsecured open ports. Once these vulnerabilities have been identified, an action plan can be drawn up, including security measures to reduce the risks. We use industry standards such as OWASP Top 10 to configure the scanning process. How can the service help you? We will provide complete scan reports as well as recommendations to lower the residual risk level and attack surface of your system. Together with a risk analysis, they can be used as a complete set of evidences towards authorities and customers. How the service will be delivered? Our team will carry out comprehensive vulnerability analysis for your software product, and help you define the most appropriate action plan, taking into account your specific requirements and context. We scan your system using automated tools to detect known vulnerabilities or weak points that could be exploited by attackers. This method involves the use of specialized software to identify security flaws, such as obsolete software versions, incorrect configurations or unsecured open ports. Once these vulnerabilities have been identified, we define with you actionable recommendations including security measures to reduce the risks. Optionally, we can complement with an analysis of the source code by a tool that will scan the whole codebase searching for security violations. This will further improve the cyber-resilience of your product. Optionally, we can perform the security risk analysis of your product. Service deployment: The service is usually "deployed" by simply having remote access to your product, so as to execute the vulnerability scanning. For the optional source code analysis, we need access to the code base. Resources provided to client: Cybersecurity tests report Recommendations Method reference: OWASP Top 10