@jshellito what are your thoughts on creating a terminology “map” so that manufacturers don’t have to overhaul as much?

It does, thanks so much Joe!

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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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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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)?

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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I imagine it will depend on the stage of a manufacturer – if it is a startup, I think it would make most sense to adopt the 13485 language. For existing manufacturers with robust quality systems and many documents, I imagine that it will be handled procedurally, where the glossary will map the terminology but they will continue to use the…

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