Thursday, 10 October 2019 (8:00 AM) - Thursday, 10 October 2019 (3:30 PM) (Amsterdam)
Damrak 1-5, 1012 LG
REGISTRATION NOW OPEN!
Through 8 September 2019
From 9 September 2019 through 4 October 2019
*Netherlands charges 21% VAT
This workshop will review the current and evolving governing regulatory requirements both in the EU and US for SaMDs. Navigating the expectations for software products is particularly challenging and requires a different approach to 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. Performing risk management/assessments for software is generally more challenging, so 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.