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Peter joined the group
a year agoFDA a year ago -
Peter joined the group
a year agoConsulting a year ago -
Jenn joined the group
a year agoindieFeed a year ago -
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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The U.S. federal government is now in a shutdown, effective October 1, 2025. Below is what the MedTech community should know — and how to keep perspective through the disruption. Good news? Most of the existing MedTech review work is funded by user fees, and as a result, the FDA has a bit of cushion to continue their critical work even during…
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Reply to QMSR Transition: Medical Device File vs. DMR/DHF
Hi Joe – quick question, are you remediating anything old, or just plan to implement the new language moving forward (and I suppose for up-revs of existing documentation)?
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Anchal joined the group
a year agoindieFeed a year ago -
Reply to QMSR Transition: Medical Device File vs. DMR/DHF
Hey Michelle – Good morning,
I’m with a startup company now, and I’ve organized a quality plan to phase out the much of the QSR lingo to align with ISO 13485:2016/QMSR terminology. Aside from the language, other aspects of my quality plan involve a review of other core processes, such as complaint handling, medical device reporting (i.e.…
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