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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