Hi Holly, I would love to share the definition comparison. I am unable to upload to this site. Any help would be appreciated. TY

That would be great, thanks Jude!

Hi Holly, I think that would be a valuable tool to help facilitate common understanding of similar terms. I do think the transition to a common 13485 terminology may take years as these terms are well ingrained into corporate culture. Would you like me to put something together ?

@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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With FDA’s new QMSR aligning to ISO 13485, one big question is terminology. ISO uses Medical Device File (MDF), while the old QSR terms Device Master Record (DMR) and Design History File (DHF) are still deeply rooted. Curious to hear how others are planning their QMS updates and what you think auditors and regulators will expect. Do you see the…

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