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QSR Author Says FDA – Not Industry – Will Need Most Time To Adapt To New Quality System Reg

US Regulatory Roundup, August 2021

 
• By Shawn M. Schmitt

Predictions made by Kim Trautman, lead author of the US FDA’s Quality System Regulation, and four other top medtech experts regarding the agency’s upcoming harmonized QSR topped our list of most-read Medtech Insight articles in August.

Top Stories US

The lead author of the US Food and Drug Administration’s Quality System Regulation predicts that device makers won’t need as much time as the agency to adapt to a new QSR that’s harmonized with international quality systems standard ISO 13485:2016.

“Under the assumption that FDA is successful in their intended purpose of further harmonizing [the Quality System Regulation] to match...

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