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    ISO-13485-blog

    Tag: “regulatory classes”

    How to use ISO 13485 to fulfill FDA regulatory classes for medical devices
    As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable...
    As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable regulatory requirements to market your products. Compliance with regulatory requirements is given equal importance in...