. Medical Device Quality Management System Certification | BSI
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    Medical device quality management system certification
    • Brochure
      Medical Devices

    Medical Device Quality Management System Certification

    ISO 13485 is the harmonized standard for Quality Management System (QMS) in the medical device industry.

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    In this document:

    • Understanding Medical Device Quality Management System Certification

    • EN ISO 13485 and CE marking

    • The importance of EN ISO 13485

    • Why choose BSI?

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