Skip to Content

Clinical validation

Virtual
Pricing/Discount Options: Call #2
Unique Identifier: f6e9d26a-8476-482c-8874-cec41e3dac2d

Service Description

Assessment of AI solutions within real-world clinical environments by healthcare and IT professionals. This service covers the entire testing lifecycle: from formative assessments (iterative clinician feedback to refine the product and its integration) to summative validation (structured performance testing against predefined KPIs). It ensures AI solutions are safety and clinically accurate, and optimized for user adoption, workflow efficiency and security.

Offerings: Testing Conformity & Compliance Algorithms/Models (transparency, accountability, privacy, fairness, reliability, etc.)
Provider Logo

Provider & Contact

Provider Country Belgium
Published Email tefservices@humani.be

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs Study protocol, regulatory requirements, and relevant clinical documentation (e.g., informed consent forms, investigator brochures)
Service Outputs Comprehensive reports
Service Standards
  • International guidance and norms (Good Clinical Practice (ICH-GCP), ISO14155, etc.), and Belgium national laws and royal decrees (loi du 7 mai 2004 relative aux expérmentation sur les êtres humains, loi du 22 décembre 2020 sur les dispositifs médicaux, AR 18-05-2021 relatif aux investigations cliniques de dispositifs médicaux, etc.)
  • Where applicable: EU regulations (AI Act, EU regulations 2017/745-746 and 2020/561 on medical devices (MDR), General Data Protection Regulation (GDPR), etc)