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Regulatory Globe|2 December 2020

MDSAP vs ISO 13485:2016 Checklist

The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation phase.

The MDSAP vs. ISO 13485:2016 checklist supports you in assessing all requirements and help to track those during the implementation phase. (Based on the MDSAP Companion document / FDA).

Benefits:

  • Simple overview / No paper chaos
  • Easy to sort by specific county requirements
  • The checklist supports well during the implementation
  • Helpful overview during the next MDSAP audit

What you get:

  • Instruction for use
  • Technical Support
  • Customer feedback improved tool

For manufacturers who are not established in the Union, the EU Authorised Representative plays a pivotal role in ensuring the compliance of the devices produced...
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