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QMSR Quick Take: Attorney Dennis Gucciardo, Medtech Insight

Tuesday, March 1, 2022

In a Q&A with Medtech Insight, partner Dennis Gucciardo discusses the US Food and Drug Administration’s (FDA’s) proposed Quality Management System Regulation (QMSR). The long-awaited amendments will replace the agency’s current Quality System Regulation.

Commenting on some of the key provisions in the draft rule, Dennis noted that the “FDA makes it explicitly clear that a third-party certification for ISO conformance will not replace routine FDA inspections.” In addition, he called attention to the implementation period for the Quality Management System being “effectively one year post-finalization of the rule.” Finally, he added, QMSR “is an opportunity for companies to dust off and shape up their procedures.”

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