Joe
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Joe updated their profile 4 days ago
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4 days agoRegulatory 4 days ago -
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4 days agoeQMS 4 days ago -
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4 days agoCodon Partners Career Corner 4 days ago -
Does anyone want to talk about P1/P2 values as part of the risk management process?
Some FMEAs include them, some do not, and Im looking to expand/broaden my knowledge on how to interpret risk management files that dont specifically call them out.
Note (Per ISO 14971): Risk = Severity x (P1xP2)
I think the explaination is that:
If you can mitigate…
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Joe joined the group
8 weeks agoRisk Management 8 weeks 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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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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Joe joined the group
4 months agoQuality 4 months ago -
Joe changed their profile photo 5 months ago
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