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FDA’s QMSR: 3 Experts Read Draft Rule Comments So You Don’t Have To. Here’s What They Saw, MedTech Insight

Wednesday, May 25, 2022

In the first of a two-part series analyzing various stakeholder comments on the US Food and Drug Administration’s proposed Quality Management System Regulation, partner Dennis Gucciardo shared insights on comments from the Medical Device Division of the American Society for Quality.

“It will be interesting to see what they do with this piece. Because I do think this is a difference between [International Organization for Standardization] ISO audits and the fact that, you know, ISO doesn't have this prohibition. And I think it is sort of standard practice to provide this information,” said Dennis. “And look, I do think it will have a chilling effect. If for some reason companies think that their management review records or internal audit records will be subject to inspection, I think that's a concern.”

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