Webinar - Clinical Evidence for SaMDs (IVD) - What IVDR really requires, and how to obtain clinical evidence for your IVD SaMD
For SaMDs classified as (part of) an IVD, scientific validity, analytical performance, and performance evaluation challenge classical clinical evidence gathering. In this webinar, we'll guide you through the 'how,' based on QbD Group's real-world experience.
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.
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