FDA’s Plan to Replace QSR With ISO 13485: Pros and Cons
May 29, 2019
By Cindy Fazzi
The U.S. Food and Drug Administration (FDA) plans to replace the Quality System Regulation (QSR) with ISO 13485. An announcement of a formal rule change is expected this fall, so GxP Lifeline asked three medical device industry experts and the Advanced Medical Technology Association (AdvaMed) to weigh the pros and cons of the plan.
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