Clinical Evidence for SaMDs (IVD)

    What IVDR really requires, and how to obtain clinical evidence for your IVD SaMD

    🕐 3:00 PM CEST / 9:00 AM ET / 6:00 AM PT

    Under IVDR, IVD manufacturers bringing software-driven diagnostic solutions (SaMDs classified as IVDs) to the EU market face specific and often underestimated clinical evidence requirements. Scientific validity, analytical performance and performance evaluation for SaMDs classified as (part of an) IVD challenge classical clinical evidence gathering, and few companies come prepared.

    This webinar addresses those requirements directly: what clinical evidence is needed, how the process maps to IVDR obligations, and what QbD Group recommends based on real-world experience. Content is pitched at a medium level, accessible to both established IVD companies and startups navigating SaMD classification for the first time.

    Agenda

    45 minutes presentation + 15 minutes live Q&A, with live chat and polls

    What You'll Learn

    • What clinical evidence under IVDR actually requires for software-driven diagnostic solutions classified as IVDs
    • How verification and validation effort for SaMDs aligns with performance evaluation
    • How to approach performance evaluation and map it to your IVDR obligations
    • Practical recommendations from QbD Group's real-world experience supporting IVD manufacturers through this process

    Speakers

    Pieter Smits

    SaMD expert & Project manager, QbD Group

    Pieter Bogaert

    Senior Consultant RA IVD, QbD Group

    Who Should Attend

    This session is built for regulatory, clinical, and product teams navigating IVDR clinical evidence requirements for software-driven diagnostics.

    • Regulatory Affairs Managers, QA/RA Directors, and Heads of Regulatory at IVD companies
    • Clinical Affairs Managers responsible for performance study design and clinical evidence documentation under IVDR
    • CTOs, Heads of Product, and Founders at IVD startups developing software-driven diagnostic solutions
    • External RA/QA consultants and regulatory liaisons supporting IVD manufacturers
    • IVD manufacturers, EU and non-EU (US, China, Israel, South Korea, Australia) seeking EU market access for IVD SaMDs