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FDA’s QMSR: 3 Experts Read Draft Rule Comments So You Don’t Have To. Here’s What They Saw

Part 1 Of 2

 
• By Shawn M. Schmitt

Longtime industry experts Kim Trautman, Steve Niedelman and Dennis Gucciardo spoke with Medtech Insight about interesting or insightful stakeholder comments on the US FDA’s proposed Quality Management System Regulation. Part one of two.

stack of white paper
• Source: Shutterstock

As of 25 May the US Food and Drug Administration has released online 50 stakeholder comments on its draft Quality Management System Regulation. When finalized, the QMSR will replace the agency’s aging Quality System Regulation (QSR).

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