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Clause-by-clause explanation of
ISO 13485:2016

Download a complimentary white paper (PDF)

This white paper explains each clause of the ISO 13485:2016 standard, while providing guidelines on what needs to be done to meet each requirement. You will also learn:

  • How to apply a process approach
  • The most important terms and definitions used in the standard
  • How to plan, implement, maintain, and improve your QMS

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