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    Using Standards to Demonstrate Conformity - Asian scientist people in laboratory for online data analytics
    • Whitepaper
      Medical Devices

    Using Standards to Demonstrate Conformity

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    Standards provide a voluntary means of demonstrating conformance

    The application of standards in the medical devices sector has undoubtedly been accelerated by their use to support regulation.

    • Use of standards to support regulations for medical devices

    • European harmonized standards

    • US FDA recognized standards

    • UK designated standards

    • Standards and the state of the art

    • Monitoring standards development and implementing new or revised standards

    BSI is your partner for regulatory compliance

    Discover our medical device standards and certification services below:

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    Compliance Navigator

    A digital platform transforming how medical device and IVD device manufacturers manage their regulatory documents to save time and reduce risk.

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    BSI Knowledge

    Deliver quality, improve safety and stay compliant with access to BSI’s healthcare standards. Embed best practice with a company-wide subscription.

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    Medical Devices

    Our mission is to ensure patient safety whilst supporting timely market access to medical technology in a sustainable manner

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    Speak to the Compliance Navigator team today

    Transform your document management process and stay ahead of medtech regulatory updates. Talk with our experts today and arrange a free trial.

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