ISO 13485:2016 Gap Analysis Tool - 30 pages & it's free






Essential Information

A great and proven way to establish the status of an MDMS

Whether you are going to manage the implementation yourself, or use the services of a Consultant or, as is most common, a bit of both, it is essential that you know and understand the gap that needs to be bridged to get your quality system from where it is now to the standard of compliance needed to secure Certification to ISO 13485:2016.

  This is one of the comprehensive Course Materials included with our ISO 13485 courses.

With this tool you can ...

  • Identify where you comply, or nearly comply, with requirements - not much work needed and you or your staff can deal with the revision. But look out for the 130+ instances calling for documentation.
  • Identify where there are deviations from the Standard - you will likely need to undertake revisions and re-training here
  • New requirements - you may need new training to understand what's required here (e.g.context of the organization or the risk-based approach)
  • Overall, you will have a rational and solid base upon which to build your ISO 13485:2016 implementation project.


Get your own copy of our ISO 13485 Gap Analysis tool by completing the form below.