Infographic: Path to ISO 13485:2016 Certification

Infographic - Path to ISO 13485 MDMS Certification.jpg

Practical steps for an easy transition

After the end of March 2019, a certificate to ISO 13485:2003 and EN ISO 13485:2012 will no longer be valid.  You'd better get started.

This Infographic describes a 33-step process in 3 phases:

  • Initiating - the groundwork to ensure success and including manageent buy-in
  • Planning - progressively developing the system and accompanying documentation
  • Implentation - and the steps leading to Certification

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