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ISO - ISO 13485 — Medical devices

    https://www.iso.org/iso-13485-medical-devices.html
    ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their …

    https://www.iso.org/standard/67943.html
    This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as …

ISO - ISO 13485:2016 - Medical devices — …

    https://www.iso.org/standard/59752.html
    Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of …

Medical devices - ISO

    http://policy.iso.org/medical-devices.html
    Medical devices. The medical devices industry, with products ranging from implantable cardiac pacemakers to wheelchairs, and from diagnostic test systems to syringes …



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