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QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like

 
• By Shawn M. Schmitt

US FDA will face high hurdles as it works to write a new rule that would merge the agency's Quality System Regulation with international quality systems standard ISO 13485. That's according to Kim Trautman, a longtime industry insider who wrote the QSR in the early to mid-1990s. "It’s a clear heavy lift from a regulatory policy perspective" that could take as long as five years to complete, she says. In the meantime, Trautman offers some insight into what device-makers might see in a new hybrid quality systems regulation from FDA. She addresses everything from corrective and preventive action (CAPA) to labeling, and complaint handling to risk management – and more.

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The author of US FDA's Quality System Regulation says the agency's plan to devise a new rule by merging the QSR with ISO 13485 will be an arduous – yet necessary – task that could take until the mid-2020s to complete.

"It's a heavy lift, OK?" Kim Trautman told Medtech Insight in a July 31 interview. "It’s a clear heavy lift from a regulatory policy perspective to get it through all...

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