Yeah hey Jude, seems like these guys have you in good shape, but there is an eSubmitter software you can download and after that you should he able to directly access the gateway from your desktop. But once inside, you can select the option for FDA form 3500A.

If you also need help with assigning any of the codes associated with any MDR, let…

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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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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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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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