Tag: "MDR" - Expert Advice Community

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  • Device classification map (questionnaire) for MD/IVD

    I'd like to know if we need, for the certification puroposes, a filled device classification map (questionnaire) or if the result of classification is enough? In order words, is the chosen MD class enough or we need to show how we got to the specific MDR/IVDR class?

    To clarify bit more: we used an online software to classify the MD. We got the result, but not the path with questions and answers.

    Thank you,

    L.

  • MDR vs CFR 21

     “Is our MDR compliant Software as MedDev (SaMD) CFR compliant in USA?”  

    Gap analysis MDR vs CFR 21