Reply To: QMSR Transition: Medical Device File vs. DMR/DHF

  • Holly

    Organizer
    September 23, 2025 at 3:35 pm

    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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