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QUOTED. May 8, 2018. Kim Trautman.

Executive Summary

US FDA is seriously considering swapping its Quality System Regulation for ISO 13485. See what NSF International's Kim Trautman, who authored the QSR in the 1990s, had to say about it here.

"It would take some time. It is not a short process. It is not going to be a fast process. It would be noble in cause, but a lot – a lot – of work." –Kim Trautman, executive VP of medical device international services, NSF International

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