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QMSR Quick Take: Attorney Dennis Gucciardo

 
• By Shawn M. Schmitt

Morgan Lewis partner Dennis Gucciardo gives a quick take on the US FDA’s proposed Quality Management System Regulation. The QMSR would replace the agency’s current Quality System Regulation.

QSR Quick Take
• Source: Shutterstock

Dennis Gucciardo is a partner at the law firm Morgan Lewis.

This is his quick take on the US Food and Drug Administration’s proposed Quality Management System Regulation. The QMSR would replace the agency’s current Quality System Regulation. The QMSR harmonizes the QSR with international quality systems standard ISO 13485:2016

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