Consulting services

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.

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

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

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

RISE Research Institutes Of Sweden

Method description: Investigate Data to be usable in an AI context. The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine learning.

Multitel (MULTITEL)

Applicable requirements for AI-based SaMD are identified, including MDR classification (Class I, IIa, IIb, III), IEC 62304, ISO 14971, IEC 62366, and the EU AI Act. A structured gap assessment is then performed across intended purpose, software documentation, risk management, usability, and clinical evaluation. Findings inform a tailored, step-by-step documentation roadmap targeting Class IIa. Recommendations on technical aspects including accuracy, robustness, validation, and end-to-end traceability from requirements to risks to tests, establishing a sound basis for the technical file.

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

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.

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Assisting companies on how to utilize extended reality technologies within their company. Either with their current services and products,with new products or for training and orientation.

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

CEED - Charité Healthcare Services GmbH

We develop customized processes, SOPs, and templates tailored precisely to your regulatory requirements.With our clinic-oriented support for generating clinical data, we offer comprehensive assistance with data collection and analysis, as well as access to relevant resources, such as through our university hospital Charité - Universitätsmedizin Berlin. We also assist you in utilizing Real-World Data to collect and evaluate practical data. Furthermore, we conduct literature and database searches to efficiently gather and analyze the necessary information for your clinical studies and clinical evaluations. Keywords: Clinical Data, Data Collection, Data Analysis, Charité - Universitätsmedizin Berlin, Literature Review, Database Research, Data, Real-World Data, RWD, Real-World Evidence, RWE

CEED - Charité Healthcare Services GmbH

Our support for conducting the clinical evaluation of medical devices includes comprehensive planning and concept development for your specific clinical evaluation. We develop customized processes, SOPs, and templates tailored precisely to your regulatory requirements. We take care of the creation and continuous updating of the necessary documents, such as the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER), to ensure that your clinical evaluation meets the highest standards. Keywords: Clinical Evaluation, Clinical Evaluation Plan, CEP, Clinical Evaluation Report, CER, Charité - Universitätsmedizin Berlin

Karolinska Institutet (KI)

Comprehensive validation and optimization of Large Language Model implementations in clinical environments through rigorous testing methodologies, prompt engineering, and output verification with healthcare professionals. Our service includes: LLM Output Validation: Consulting advice on systematic evaluation of LLM responses against clinical guidelines, medical literature, and expert validation to detect hallucinations, factual errors, and inappropriate recommendations. Collaboration with medical staff to assess clinical relevance, safety, and appropriateness of generated content. Prompt Engineering Optimization: Development and refinement of clinical prompts using few-shot learning, chain-of-thought reasoning, and structured output formats. Testing prompt variations against real clinical scenarios to maximize accuracy, consistency, and safety. RAG Implementation & Validation: Design and validation of Retrieval-Augmented Generation systems using verified medical knowledge bases, clinical guidelines, and institutional protocols. Ensuring retrieved context is relevant, current, and properly integrated into LLM responses. Clinical Finetuning Strategy: Assessment and guidance on finetuning approaches for clinical use cases, including dataset curation, domain adaptation, and continuous learning strategies. Evaluation of finetuned models against baseline performance and clinical benchmarks. Bias Detection & Mitigation: Identification of demographic, diagnostic, or treatment biases in LLM outputs across diverse patient populations and clinical scenarios. Keywords: Large Language Models; Clinical NLP; Prompt Engineering; Output Validation; Hallucination Detection; RAG Systems; LLM Finetuning; Medical Knowledge Bases; Clinical Guidelines Compliance; Bias Mitigation; Healthcare AI Safety; Human-in-the-Loop Validation; Trustworthy Clinical AI

CEED - Charité Healthcare Services GmbH

Our Clinical Needs Analyses focus on examining specific requirements and needs within the clinic. This can include evaluating processes, workflows, or medical equipment to derive measures and product ideas that improve the efficiency, effectiveness, and quality of patient care, as well as the working conditions of clinical staff. The analyses enable products to be tailored to the specific needs and requirements of the clinic, fostering market-oriented innovations and enhancing efficiency and customer retention. Our Medical Needs Analyses focus on investigating requirements and needs in healthcare, including assessing the current state of research and technology. The analyses provide insights into the prevention, diagnosis, and treatment of diseases, as well as trends and challenges. They serve as a foundation for developing new products and services that meet or exceed current medical standards and support targeted innovation and effective resource utilization. Keywords: Clinical Expertise, Clinical Requirements, Medical Requirements, State of the Art, Market Needs, Literature Research, Interviews, Workshops, Workplace Analyses

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 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;

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

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;

Istituto Giannina Gaslini (IGG)

Our service can provide consulting for designing Clinical Trials in a realistic pediatric environment; Ethical commettee documentation; Pediatric environment; Clinical trial roadmap; Statistics; best trial type determination. Prices are subject to change and are only indicative. The final price will be determined in the contract between the service provider and the applicant.

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

Technische Universitaet Muenchen (TUM)

Consulting activities to enable usage by customers of a virtual testing and experimentation facility for robotic simulation, with a view to achieve one of more of the following outcomes: in silico training and optimization (e.g., reinforcement learning, genetic algorithms, etc.), performance evaluation of AI-based controllers for robotics in virtual testing environment, or definition and implementation of testing & benchmarking scenarios on specific simulators (e.g., Unity, PyBullet, MuJoCo, etc.). Keywords: Robotics; Simulation of modular heterogeneous systems; In silico functional evaluation of algorithms and AI models for robotics; Optimization of algorithms and AI models for robotics

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

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 The Data Feasibility Service provides an early, structured assessment of whether the health data required for AI validation can realistically be accessed and used within the Swedish healthcare and research data ecosystem. The service focuses on feasibility and risk reduction rather than data delivery. Karolinska Institutet experts assess whether relevant data sources exist, where they are located, and whether the data’s structure, quality, and technical characteristics are suitable for running and validating the proposed AI solution. Legal, ethical, and practical constraints are reviewed at a high level. The outcome is a concise, actionable feasibility assessment supporting informed decisions on whether to proceed with AI validation and potential next‑step data acquisition services. How can the service help you? Before the service, organisations often face uncertainty around data availability, technical suitability, timelines, and regulatory barriers. After the service, they gain a realistic understanding of whether the required data can support their AI model in practice, including whether the data format, volume, and quality are compatible with the intended validation approach. This enables clearer go/no‑go decisions, improved validation planning, and early alignment with clinical relevance and regulatory expectations, reducing the risk of costly delays or infeasible projects. How the service will be delivered? The service is delivered through a structured review led by Karolinska Institutet in dialogue with the requesting organisation. Experts analyse the proposed use case, data needs, and AI requirements against known Swedish data infrastructures and governance frameworks. The work is primarily desk‑based and typically completed within a few weeks, depending on scope. No transfer or processing of health data is required as part of this service. 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 Feasibility is assessed by mapping potential data sources and reviewing governance, access pathways, and constraints. The assessment includes data structure, format, completeness, and quality, as well as technical feasibility aspects such as whether the data can support the intended AI model, validation design, and computational requirements. Legal and ethical considerations, including GDPR, Swedish legislation, and the need for ethics approval, are considered at a high level. The service informs but does not replace formal ethics or data access applications. Service customization The service can be tailored to different clinical domains, data types (e.g. imaging, registries, EHRs), and maturity levels of organisations. The depth of analysis depends on the clarity of the use case and data requirements. The service is limited to feasibility assessment and does not guarantee data access or approval by data owners. Use case/ example An SME developing an AI‑based clinical decision support tool requests access to retrospective imaging and outcome data. The service assesses data availability, governance constraints, and whether the data’s structure and volume are technically suitable for running and validating the AI model. The results indicate feasible data sources but significant lead times, guiding the SME to refine its validation strategy before proceeding with full data acquisition.

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.

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)

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 support service offer to companies scientific and methodological advices 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 Warehouse. He will ensure project managment in our institution and key steps related to clinical data warehouse exploitation (e.g., submission to local ethics and scientific comitee).​    - Regular meetings including a group of experts specialized in medecine, 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 "Feasabilty 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 ressources:     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 Grenoble (CHUGA)

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 with French regulatory authorities*. It offers the opportunity to have several documents reviewed and evaluated by experts as some help for deposit. 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 regulatory 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 "Feasability study" must have been previously conducted. Method Description: Depending on the SME needs and available ressources, this service may include all or part of the following task list:     Analysis of legal and ethical framework by our Institutional Review Board (IRB) [optional]     Compliance assessment (Category of research, legal compliance, etc.) [optional]     Assistance and advice on building regulatory files [optional] Method reference: Local method respecting General Data Protection Regulation (GDPR), *French regulatory autorities :     Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé (CESREES),     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 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

Centre Hospitalier Universitaire De Grenoble (CHUGA)

This service aims to formalise and consolidate the SME 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 factor, factors linked to objectives, confounding factors     - Scope : Clinical data warehouse/French health insurance medico-administrative data (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)

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

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;

HUMANI SC - Hospital network (HUMANI)

Access to clinical and data experts to identify dataset needs.

CEED - Charité Healthcare Services GmbH

Our expert panels and workshops bring together professionals from various clinical areas to provide valuable insights and expertise during early concept, planning, design, and development phases. This collaboration allows for discussions of product ideas, evaluation of technical details and design aspects, identification of potential challenges, and development of innovative solutions that meet the needs of users and patients while adhering to the highest standards. Keywords:Expert Panels, Group Discussions, Clinical Expertise, Requirements Analysis, Workshops, User and Clinical Requirements, Requirements Engineering, Usability Engineering

Metropolia Ammattikorkeakoulu Oy (METROPOLIA)

Helping companies to evaluate and test extended reality technologies before investing in them. Assisting them in creating new ideas on how to utilize the technologies in their selected field.

Health Data Hub (Plateforme des Données de Santé)

This service focuses on technical validation. It provides rigorous evaluation of experimental design, statistical power, reagent specificity, and controls to ensure methodological integrity and data reliability, identifying potential biases or flaws before study commencement.

Health Data Hub (Plateforme des Données de Santé)

This service offers comprehensive scientific protocol authorship, generating detailed, technically sound protocols tailored to your research objectives. It encompasses experimental design, statistical considerations, precise methodological steps, and robust control measures, ensuring clarity and reproducibility for complex studies.

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

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.

Karolinska Institutet (KI)

## Overview This service provides expert regulatory support for startups, SMEs, and research projects working on AI-based and digital medical technologies. Provided by SMAILE at Karolinska Institutet, the service helps navigate the complex requirements of the EU Medical Device Regulation (MDR), especially for software as a medical device (SaMD), wearable devices, and AI-powered diagnostics. Guidance includes risk classification, conformity assessments, documentation gap analysis, and strategy development. We provide expertise and support in: • EU MDR readiness and gap analysis • Regulatory strategy for AI-based and digital devices • Documentation review for CE-marking ### How can the service help you? Whether you’re preparing for a clinical trial or a CE submission, this service helps reduce regulatory risk and accelerates your go-to-market process. It is particularly valuable for early-stage developers unfamiliar with MDR Annexes, UDI, and performance evaluations. ### How will the service be delivered? Delivered virtually, with review sessions and feedback meetings. For complex projects, hybrid support is available, including hands-on workshops at the Karolinska Institute. Timeline varies: from a 1-week consultation to a 6-week full regulatory mapping. ## Additional Information ### Provider Description SMAILE supports startups and innovators through regulatory guidance for digital health and AI technologies. The team includes experts in MDR, AI Act, clinical evaluation reports (CER), and technical documentation for medical devices. ### Technical Description The service includes mapping your product against MDR Annex VIII, evaluating classification and intended use, and reviewing QMS and risk management documentation. ### Service Customization Custom modules include technical documentation audits, clinical evaluation design support, and guidance for combination products or health apps.

CEED - Charité Healthcare Services GmbH

Our medical device advisor training is aimed at all employees of medical device manufacturers and trading companies who inform about medical devices and provide training on their use. The training delivers practical, product- and company-independent fundamental knowledge required for this role. It clearly outlines the rights, responsibilities, and obligations of medical device advisors and is supported by the legal requirements of the MPDG and MDR. It is suitable for both new professionals entering the field and for updating and refreshing existing knowledge. Keywords: Training Concept according to MPDG, Rights and Responsibilities of Medical Device Manufacturer Employees, Fundamental Knowledge, Clinical Insights, On-Site or Online

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

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.

CEED - Charité Healthcare Services GmbH

Our clinic-oriented Post-Market Clinical Follow-Up (PMCF) support offers you comprehensive assistance with the planning and development of your PMCF activities. We develop customized processes, SOPs, and templates for updating the clinical evaluation, precisely tailored to your regulatory requirements. Our service includes the creation of all necessary documents, including the PMCF Plan and Report. Additionally, we support you in conducting PMCF studies, registries, and surveys, particularly at the university hospital Charité. With our expertise, we ensure that your PMCF activities not only comply with regulatory requirements but also provide valuable data for the continuous monitoring and improvement of your medical devices. Keywords:Post-Market Clinical Follow-Up, PMCF, Clinical Evaluation Update, PMCF Plan, PMCF Report, PMCF Studies, Register, Surveys, Charité - Universitätsmedizin Berlin

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

CEED - Charité Healthcare Services GmbH

Our Post-Market Surveillance (PMS) support offers comprehensive assistance with post-market monitoring, such as planning and developing your PMS activities. We develop customized processes, SOPs, and templates precisely tailored to your regulatory requirements. Additionally, we handle the creation and regular updating of important documents such as the PMS plan, PMS report, and Periodic Safety Update Report (PSUR). Keywords: Post-Market Surveillance, PMS, Post-Market, PMS activities, PMS plan, PMS report, Periodic Safety Update Report, PSUR, safety report, trend analysis, continuous surveillance, Charité - Universitätsmedizin Berlin

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

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)

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)

# Overview This service delivers specialized technical guidance on detecting, evaluating, and mitigating systematic biases within medical datasets and across differing data sources. Hidden disparities in training data arising from variations in measurement hardware, operator techniques, or study protocols can severely compromise algorithm accuracy and lead to unexpected performance drops when deployed in real-world clinical environments. The primary objective is to give startups and digital health developers a structured approach to uncovering hidden data imbalances, ensuring machine learning models are trained on representative, reliable data. ## How can the service help you? Unidentified biases in training datasets often cause machine learning models to learn unintended shortcuts rather than genuine biomedical signals, leading to poor generalization. This service provides actionable diagnostics to identify and correct these vulnerabilities early. - *Before:* Unchecked datasets where subtle device-level differences or operator variations risk distorting model training and output validity. - *After:* A comprehensive bias assessment identifying data collection artifacts, demographic imbalances, and hardware-induced variations alongside concrete mitigation strategies. It empowers development teams to refine data collection protocols, enhance algorithmic robustness across different hardware, and prepare their AI solutions for rigorous clinical validation. ## How will the service be delivered? The service is conducted through remote technical consultations and analytical evaluations. Clients submit their dataset documentation, sensor specifications, and study protocols via secure digital channels. Our experts analyse the data structures and protocols, then present findings and recommendations in a structured review meeting. # Additional information ## 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 evaluation employs both exploratory data science and explainable AI (XAI) techniques to systematically identify hidden dataset discrepancies: - *Input Data Requirements:* Sample datasets and/or documentation detailing data collection procedures, sensor output specifications, and clinical study protocols. - *Core Tasks & Processing:* Unsupervised cluster analysis (e.g., k-means, t-SNE/UMAP) to identify systemic data clustering driven by operator or hardware variations; Explainable AI methods for supervised models to verify whether the algorithm relies on genuine physiological features rather than dataset artifacts. - *Outputs:* A comprehensive analysis report highlighting identified dataset limitations, confounders, and recommendations for protocol adjustments or data re-balancing prior to model training. ## Service customization The engagement scope is adaptable based on project needs. Clients can opt for an initial review of collection protocols before gathering data or request a full analytical evaluation of existing multi-center datasets to isolate hardware-specific biases.

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

# Overview This service delivers specialized technical guidance on data handling, data architecture, and dataset standardization tailored for digital health applications. Proper data structure is critical when training and validating robust machine learning algorithms. Through tailored evaluations, our experts review your existing data collection workflows and propose unified schemas, interoperable formats, and clean data storage models. The primary objective is to help organizations eliminate data silos, streamline machine learning pipelines, and ensure their medical datasets meet modern data management standards such as making research data findable, accessible, interoperable, and reusable (FAIR). ## How can the service help you? Disorganized, non-standardized datasets introduce training errors, inflate pre-processing overhead, and create regulatory hurdles during product validation. This service establishes a solid structural foundation for your data engineering efforts. - *Before:* Fragmented data stored in non-standard formats with inconsistent metadata, requiring extensive manual cleaning before every machine learning experiment. - *After:* A clean, optimized data infrastructure plan aligned with machine learning requirements and data governance standards. It equips engineering and clinical teams with concrete recommendations to optimize data retrieval, improve model scalability, and ensure long-term data reusability. ## How will the service be delivered? The service is conducted remotely through structured technical consultations and document reviews. Clients share their proposed data collection plans, sample schema files, or description of existing database architectures. After analysing the setup, our experts deliver a comprehensive data standardization report and review findings. # Additional information ##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 Our recommendations leverage established open-source data formats, healthcare interoperability guidelines, and FAIR data principles. - *Input Data Requirements:* Proposed data management plans, storage schemas, API documentation, or anonymized sample datasets. - *Core Tasks & Processing:* Metadata audit, data model mapping, analysis of storage/retrieval speed, evaluation of machine learning feature compatibility, and FAIRness compliance review. - *Outputs:* A structured data infrastructure proposal containing dataset standardization guidelines, recommended metadata schemas, and actionable pre-processing recommendations. ## Service customization Clients can tailor the advisory scope based on their current stage of development. Startups and SMEs can opt for a high-level review of a single collection plan or request an in-depth infrastructure audit covering multi-modal sensor inputs, database pipelines, and machine learning storage architectures.

Friedrich-Alexander-Universitaet Erlangen-Nuernberg (FAU)

# Overview ## How can the service help you? Deploying black-box or fragile AI models creates severe compliance risks, reduces stakeholder trust, and increases the likelihood of unpredictable model failure in clinical practice. This service helps overcome these hurdles by establishing clear testing methodologies. - *Before:* An opaque AI algorithm evaluated only on standard validation metrics, with unknown vulnerability to noise, distribution shifts, or interpretability bottlenecks. - *After:* A robust testing strategy equipped with actionable frameworks for evaluating model decision-making, adversarial resilience, and multi-metric performance. It enables development teams to build trustworthy AI systems, streamline technical documentation, and align their validation workflows with emerging regulatory and evaluation standards. ## How will the service be delivered? The service is delivered remotely through expert evaluation sessions and technical consultations. Clients provide model architecture specifications, validation data protocols, and system documentation. Our experts assess the setup against established testing frameworks and present targeted recommendations in a technical report and review session. # Additional information ## 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 advisory framework incorporates peer-reviewed methods for evaluating transparent, secure, and reliable machine learning architectures: - *Input Data Requirements:* AI model files, architecture descriptions, dataset specifications, and current validation documentation. - *Core Tasks & Processing:* Audit of model explainability methods (e.g., attribution maps, feature importance metrics), evaluation of robustness testing techniques (e.g., sensitivity to input noise, distribution shifts, adversarial perturbation analysis), and setup of multi-dimensional performance validation metrics. - *Outputs:* A comprehensive recommendation report detailing concrete protocols for testing explainability, stress-testing model robustness, and setting up rigorous performance benchmark pipelines. - *Scientific Reference:* Aligned with peer-reviewed methodologies for reliable AI evaluation ([DOI: 10.1007/s10489-023-04532-5](https://link.springer.com/article/10.1007/s10489-023-04532-5)). ## Service customization Clients can tailor the advisory scope to focus on specific testing pillars based on project priority such as focusing exclusively on Explainable AI (XAI) validation to increase clinical transparency or prioritizing adversarial robustness testing for edge-case failure detection.

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)

Compliance with IVDR requires a Performance Evaluation, including the assessment and analysis of data to establish or verify the scientific validity, the analytical performance, and, where applicable, the clinical performance of an IVD. IPN’s support in this area includes: • Development of the Performance Evaluation Plan (PEP) • support in demonstrating the scientific validity and the analytical and clinical performance • Elaboration of the Performance Evaluation Report (PER) • Gap Analysis on scientific validity, analytical and clinical performance data This service provides a structured and regulation-compliant approach to performance evaluation, facilitating both regulatory approval and the ongoing lifecycle management of IVD devices.

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.

CEED - Charité Healthcare Services GmbH

Our company-specific modular MDR-workshops offer hands-on training on various relevant topics of the Medical Device Regulation (MDR) and the general medical device field. These intensive workshops are divided into compact and practice-oriented modules that cover the key requirements of each respective topic. An example is the Module 1 workshop “Regulatory Requirements for Your Medical Device,” which provides a compact and practice-oriented overview of the key regulatory requirements in the medical device field. The workshop content is tailored to the company’s specific needs beforehand, and additional topics can be booked in modular fashion. Thus, specific topics such as Clinical Evaluations, Technical Documentation, and Quality Management can be booked individually and customized to the company's needs. The content is structured in such a way that participants are optimally prepared for the MDR requirements and can directly apply their knowledge. A regular workshop usually lasts two days and includes gap analyses in the form of checklists as well as the creation of an action plan. Practical exercises additionally introduce the creation of documentation and processes tailored to the individual company. Participants also receive current informational materials and clinical insights from practice. Our workshops provide companies with the opportunity to not only further educate individual employees but also empower their team to implement the MDR and other regulations within the company. Our goal is to strengthen and support the team in jointly managing the various regulatory requirements and to guide the transition from overview and understanding to practical implementation. Keywords: MDR Workshop, MDR, Medical Device Regulation, Modular Workshops, Hands-On Training, Medical Devices, Regulatory Requirements, Practical, Gap Analyses, Action Plan, Clinical Evaluation, Quality Management, Usability, Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Charité - Universitätsmedizin Berlin

CEED - Charité Healthcare Services GmbH

Our clinic-oriented regulatory strategy consulting offers comprehensive, individualized advice and support on specific issues in the medical device field. We assist you with product identification, clarify demarcation questions, and support product classifications as well as the selection and implementation of the conformity assessment procedure. Additionally, we maintain close contact and communication with the Notified Body to effectively meet your requirements. Our service also includes consulting on Quality Management Systems according to ISO 13485 and re-certification. Our experts support you in technical documentation, conduct gap and requirements analyses, and prepare you for inspections. We also offer internal audits to ensure that your systems and processes comply with current regulatory requirements and are continuously improved. Our consulting topics particularly include clinical evaluation, including advice on clinical strategy and clinical benefits, as well as equivalence assessment. We provide comprehensive advice on the selection of clinical data, determine the type and extent of required data, and recommend suitable data sources and methods of data collection, including Real-World Data (RWD). Furthermore, we support the assessment of evidence levels and classes, as well as ensuring data quality and quantity. In the area of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF), we offer consulting on the development of PMS and PMCF strategies and support in individual PMS and PMCF activities such as studies and surveys. Additionally, we provide advice on the establishment and implementation of usability engineering and requirement processes to optimize the usability of your medical devices. Keywords: Regulatory Strategy, Consulting, Medical Devices, Intended use, Product Classification, Conformity Assessment Procedure, ISO 13485, Technical Documentation, Gap Analysis, Inspections, Internal Audits, Clinical Evaluation, Clinical Data, Real-World Data (RWD), Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), Usability Engineering, Charité - Universitätsmedizin Berlin

CEED - Charité Healthcare Services GmbH

Our requirements analyses during design and development phases focus on the development of product ideas and include detailed investigations to identify technical, functional, and usability requirements. The analyses aim to define the exact specifications of the product, identify potential design improvements, and ensure that all development goals are met. They help in developing high-quality and marketable solutions that comply with industry standards and requirements. Requirements analyses may involve various activities, such as user interviews, workshops, and workplace and workflow analyses. Keywords: Requirements Engineering, Functional Requirements, Usability Requirements, Specifications, Usability Engineering, User Interviews, Expert Panels, Workplace & Workflow Analyses

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).

CEED - Charité Healthcare Services GmbH

CEED supports startups, SMEs and healthcare technology companies in the structured preparation of clinical, operational and regulatory projects within the Charité ecosystem. The service focuses on creating a structured foundation for subsequent clinical project implementation, including: * project scoping, * documentation review, * stakeholder alignment, * clinical and regulatory assessment, * and project and cost planning. The service addresses common early-stage challenges such as: * unclear clinical project scope, * regulatory and evidence uncertainty, * identification of suitable Charité stakeholders, * and limited transparency regarding feasibility, timelines and costs. Activities include: * review of product, project and scientific documentation, * identification and initial engagement of relevant Charité stakeholders, * initial assessment of clinical, operational and regulatory project requirements, * development of project roadmaps, * and preliminary cost and implementation planning. Depending on project maturity and requirements, the service may include integration with: * clinical departments, * institute of medical informatics, * data and research infrastructure, * regulatory and ethics interfaces, * and operational study support structures. The service is designed to establish a structured basis for future clinical validation, PMCF, real-world data or implementation projects within complex hospital environments.

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.

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)

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.

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).

Istituto Giannina Gaslini (IGG)

Our service can provide consulting on designing, modelling, validation and testing of Trustworthy AI models in a realistic pediatric environment, it can provide information on the most relevant applications, Data types, needs, pitfalls, and peculiarities of a typical pediatric environment. It can provide support for typical challenges and solutions on data governance and infrastructures with acknowledged scientists in AI for pediatric needs. Service can connect company with experts in various pediatric medical disciplines; Hospital organisation; AI applications in pediatrics; Data exchange standards and infrastructures; Optimal algorithm development and testing for pediatrics; Methods for AI testing and validation; Data science; Data types in paediatrics. Prices are subject to change and are only indicative. The final price will be determined in the contract between the service provider and the applicant.

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

RISE Research Institutes Of Sweden

Method description: Add-on support to the service "AI improvement and development" available at RISE. The service includes support for training, deployment and installation. The service is customized according to the SME's needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated learning, Data Science, AI, Deep Learning, Natural Language Processing, Computer Vision, Machine Learning.

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.

RISE Research Institutes Of Sweden

Methods description: The service of testing and validation of AI solutions with Deep Learning paradigms. The service can include suggestions of applications and highlight strengths, weaknesses, threats and/or opportunities. The service is customized according to the SME's needs. Pre-requisites for the service are the analysis of data availability, data-readiness level and customer needs. Method reference: To be refined depending on the type of task, and in dialog with the customer. The Center for Applied AI at RISE carries out cutting-edge research in AI, connects expertise and applications within RISE, and explores a wide range of innovative applications with industry and the public sector. Applied AI Centre at RISE helps companies and government agencies to see more potential in the technology, use it more wisely and develop it faster. Keywords: Trustworthy AI, Federated Learning, Data Science, AI, Deep Learning, Natural language processing, Computer Vision, Machine learning.

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

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.

CEED - Charité Healthcare Services GmbH

Our workplace and workflow analyses provide insights into the workflows and environments within the clinic, including the analysis of processes, the physical work environment, and the interaction with other devices and technologies. They can also be used to examine workflows and challenges with existing products. Workplace analyses are crucial for understanding the requirements for designing and integrating new products, ensuring that they can be seamlessly incorporated into existing workflows, taking into account user needs as well as safety and efficiency standards. Keywords:Workplace Analyses, Workflow Analyses, Process Analyses, User and Clinical Requirements, Usability Engineering