In a recent article published March 26th, it was reported that the FDA is strongly considering updating its quality system requirements for medical device manufacturers to utilize the ISO updated quality management standard, 13485:2016. What are your thoughts on FDA updating QSR to include an ISO standard? Do you think this will actually happen? What would this mean for manufacturers?

I think its completely logical for FDA to update QSR to include parts of ISO 13485:2016, because they are very similar. I’m not sure if this will actually happen or how they will integrate, but if it does I believe that it would take a while to make a a decision and implement so this would allow manufacturers enough time to make any necessary changes.

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