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QMSR Transition: Medical Device File vs. DMR/DHF
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QMSR Transition: Medical Device File vs. DMR/DHF
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 industry moving to MDF, or will DMR/DHF stick around?
How is your company approaching this?
– Switching to MDF for global alignment?
– Keeping DMR/DHF for continuity?
– Using a hybrid/cross-referenced approach?
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5 Replies
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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 same language.
Curious to see how others are handling their transition plan!
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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. Parts 803/806), document/record control (Part 11), risk management, & training. I’m not anticipating too much legwork as we are already ISO 13485-certified.
Hope this helps!
Joe
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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)?
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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 service histories, as applicable (traceability and record control). 2. We are moving to an eQMS system as a paper-based QMS (at least for us) has not allowed records to be easily or readily available for and during inspections.
Hope this helps!
Joe
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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 regulatory authorities but creates confusion within ones quality system. For your specific question I would believe that both terms will move forward interchangeably until such time as the FDA completes the transition and training of the investigators. My suggestion is to align with 13485 / 9001 terminology right away. This allows the FDA and the remainder of regulatory authorities outside of the FDA to clearly understand your Quality System documentation.
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