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
Cactus Life Sciences
Cactus Life Sciences is a medical communication company that provides scientific strategy and content across the healthcare continuum, anywhere in the world ─ with a focus on science, innovation, and efficiency. We work alongside leading healthcare companies to establish the optimal role of medicines and encourage positive behaviors (physician and patient) that improve patient outcomes.