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ISO 13485:2016 vs.
ISO 13485:2003 matrix

Download a free matrix (PDF)

This matrix shows the relationships between the requirements of ISO 13485:2003 and those of ISO 13485:2016, giving an overview of the differences. Essential to any business considering becoming compliant with the new standard, this matrix has a side-by-side format that will allow you to easily:

  • Learn what changes you should be prepared for
  • Identify which parts of the standards are similar
  • Learn how to transition to the new version with as little stress as possible
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