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This free tool will help you to convert ISO 13485:2003 clauses to the new ISO 13485:2016 clauses. Just select the number of your current clause below and you will find out:

  • Which clause in ISO 13485:2016 corresponds with it.
  • What kind of changes do you need to perform in your QMS to comply with the new revision of the standard.

Start your transition project right away, without an expensive consultant.

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Strahinja Stojanovic
Lead ISO 13485 expert

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ISO 13485 documentation

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