The latest EU-MDR guidelines are a step in the right direction, moving from a focus on the pre-approval stage of medical device manufacturing toward a life-cycle approach to medical device regulation. This surely adds to the complexity of medical device manufacturing and approval processes. How can medical device manufacturers track safety and performance objectives within the clinical evaluation process and beyond?
Vera Edgeworth (M.D.), Medical Device Solutions (MDS) Medical Director, Cactus Life Sciences, led a workshop in collaboration with Ronak Dunung, Risk Management Manager, Cook Medical, on the topic – “Data-driven QMS Alignment” at the American Medical Device Summit (AMDS) 2021, to discuss pragmatic solutions to align clinical evaluation, risk management, and key QMS processes. Here’s a sneak peek.
Watch the entire session here: https://www.youtube.com/playlist?list=PLcpImmTTyOuD5oEexnZcb22gwG75xDAnD