QMSR: The Future of FDA's Quality System Regulation

The FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016. How will the new Quality Management System Regulation (QMSR) affect medical device manufacturers and the regulatory landscape?
In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about what's on the horizon for the new medical device QMS regulation and the pros and cons of incorporating ISO 13485-a standard not governed by FDA.