EU Director Governmental Affairs Elekta Veenendaal, Utrecht, Netherlands
You can register for this Pre-Conference workshop until Friday 23 October via the RAPS Euro convergence website: https://www.raps.org/europe-2020/register. Once you have registered you will receive an email with the webcast link for the meeting. _________________________________________________________________________________________
This workshop will review the current and evolving regulatory requirements both in the EU and US for software as a medical device (SaMD). Navigating the expectations for software products is particularly challenging and requires a different approach from other medical devices. Issues to be addressed include how to determine when software is considered regulated as SaMD and how to determine correct class/classifications under US and EU requirements. The session will include practical case studies to work through completing the required evaluations. This workshop will be particularly beneficial to regulatory professionals, QA professionals and application developers who are responsible for managing and planning regulatory compliance for software products.
Welcome and Introductions (Koen Cobbaert) • Presentation – Regulation of SaMD across the world – overview & trends (Koen Cobbaert) • Distinction between SaMD, not SaMD, software integrated in a MD, medical device software - (Koen Cobbaert) • Delineation between MD and IVD software (Koen Cobbaert) • Qualification differences across the world (US, Russia, Canada, …) (Koen Cobbaert) • Case studies (Koen Cobbaert, Leo Hovestadt)
