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Reply to QMSR Transition: Medical Device File vs. DMR/DHF
Had a few minutes and thought I would add to the discussion.
Using consistent and accurate terminology is critical to assure a common understanding and alignment with regulatory authorities and within your organization. I have worked with clients that tend to create there own terminology and I can assure you it not only confuses…
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Reply to QMSR Transition: Medical Device File vs. DMR/DHF
Hey Holly – Good morning,
Yeah, great question! A lot of it will be language-based changes, however there are a few additional things we are adding: 1. QMSR incorporates UDI directly into its core requirements, specifying that UDI information must be recorded for each device or batch in records like complaint investigation records and…
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