QSR Q&A: 5 Top Medtech Experts Answer 6 Burning Questions About FDA’s Coming Quality Reg Redo

10 Aug 2021

• By Shawn M. Schmitt

For this “man on the street” feature, Medtech Insight rounded up industry experts Kim Trautman, Vincent Cafiso, Steve Niedelman, Kwame Ulmer and Josh Levin to answer six questions about the upcoming draft harmonized Quality System Regulation from the US FDA.

colorful paper with question mark as background.

Medical device manufacturers and other industry stakeholders are waiting for the draft harmonized Quality System Regulation from the US Food and Drug Administration with breath that is bated. The agency has been working on the QSR redo – which better aligns the decades-old rule with international quality systems standard ISO 13485:2016 – for more than three years now.

The draft QSR, which will become the bedrock rule for manufacturing safe and effective devices in the US when finalized,...