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    ISO-13485-blog

    Tag: “medical device files”

    How to meet ISO 13485:2016 requirements for medical device files
    The requirements for medical device files in ISO 13485:2016 are an endeavor by the ISO Technical Committee (TC 210) to...
    The requirements for medical device files in ISO 13485:2016 are an endeavor by the ISO Technical Committee (TC 210) to create consistent operations for medical device manufacturers, and also to make their Quality Management Systems...