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Clinical Research Services - Technical support (AI solutions)

TEF-Health Service
Physical Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 0753434c-304c-49fb-9ad2-75f9d29ff73f

Service Description

OVERVIEW : This service provides technical support for the deployment and evaluation of medical devices in clinical environments such as acute care areas, operating theatres, intensive care units. It includes feasibility assessments, integration of medical devices within data management infrastructures, implementation and maintenance support, connectivity and data transfer monitoring, user assistance, and the preparation of technical evaluation reports assessing the solution's performance, usability, reliability, and suitability for real-world clinical use.

HOW CAN THE SERVICE HELP YOU ? : This service helps you deploying successfully and evaluating your medical device in real-world clinical environments. By providing technical expertise, infrastructure integration, connectivity monitoring, and ongoing user support, it reduces implementation risks, ensures reliable data collection, minimizes disruptions to clinical workflows, and facilitates the generation of robust evidence on the device's performance, usability, and suitability for routine clinical practice.

HOW WILL THE SERVICE BE DELIVERED ? : The service is delivered by the HUmani’s IT Department working in close collaboration with the end-users of the solution (physicians, nurses, and other relevant healthcare professionals) and, when appropriate, with the device manufacturer or technology provider. This service is available either as a standalone offering or, where required, in mandatory combination with medical data provision and clinical investigation services for AI solutions integrated within the hospital environment.

PROVIDER DESCRIPTION : HUmani CHU Charleroi-Chimay is a hospital network composed of five general and specialized hospitals and 8 polyclinics offering healthcare services in more than fifty medical and surgical specialties. Located in Belgium, at the heart of Europe, we are strongly committed to clinical research with the support of a dedicated Clinical Research Unit offering Clinical Research Organization (CRO)-like services.

TECHNICAL DETAILS : This service is performed in compliance with the MDCG 2019-16 Rev.1 guidance, EU regulations 2017/745 (MDR), 2016/679 (RGPD), Belgian laws and Royal Decrees, and HUmani standard operating procedures.

SERVICE CUSTOMIZATION : This service may be provided by HUmani either as part of its role as the full sponsor of your investigation study or on an “à la carte” basis.

Service categories: Clinical Investigation Support
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Organisation HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
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Billing: per hour
Full Price 68–90 EUR
Reduced Price 63–83 EUR

Operational Details

Service Inputs Medical device documentation; Preliminary synopis; Project draft; Clinical investigation protocol
Service Outputs Feasability report; Monitoring reports; Technical evaluation report
Dependencies & Restrictions  
Certification Support  
Service Standards
  • Artificial Intelligence Act
  • Belgian national laws
  • EU regulations: Medical Devices
  • GDPR
  • IATA
  • International regulations: Good Clinical Practice (ICH-GCP)
Comments  

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