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10 Things You Need To Know About FDA’s Proposed Quality Management System Regulation

 
• By Shawn M. Schmitt

Longtime industry experts Kim Trautman and Eric Henry highlight some of the more important takeaways from the US FDA’s draft rule that would create a new Quality Management System Regulation, or QMSR, to replace its current Quality System Regulation.

Abstract photo of darts.
• Source: Alamy

The US Food and Drug Administration says a draft rule that aims to replace its decades-old Quality System Regulation (QSR; 21 CFR, Part 820) with a new Quality Management System Regulation (QMSR) will help harmonize QMS requirements and get medical devices into the hands of patients more efficiently.

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