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    ISO-13485-blog

    Tag: “technical documentation”

    What are the EU MDR technical documentation structure and requirements?
    The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device...
    The main purpose of technical documentation in the EU Medical Device Regulation (MDR) is to prove that a medical device meets the general safety and performance requirements. Regardless of the class, technical documentation is mandatory...