MDSAP

MDSAP

MEDICAL DEVICE SINGLE AUDIT PROGRAm – assessment tool

How to implement MDSAP

There is a companion document on the FDA page. This document has all the requirements you need to implement the MDSAP requirements in your company. But in our mind, this document is very huge and not easy to read because there are a lot of requirements and references in it. Therefore we recommend our MDSAP vs. ISO 13485:2016 Tool. It is developed in a way that makes it much easier to find all the references to the ISO 13485:2016 and to get a better overview of the requirements of each Country. If you are not sure, if this tool could be helpful for you, then just download a test version of this tool CLICK HERE to see whether it’s helpful or not.

Benefits of this tool:

  • Simple overview between ISO 13485:2016 and the Country-specific requirements
  • Overview of your company processes and which are affected by the MDSAP
  • Very helpful during the implementation phase and later during the MDSAP audits
  • Very easy to use
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