MDSAP Gap Assessment Tool


This tool contains all the requirements you need to comply with to be MDSAP Certified. There are 7 chapters that you need to go through and for each chapter, there is a list of requirements common to the 5 countries (Australia, Brazil, Canada, Japan, USA). And there are also specific requirements for each country. A link to existing regulations is made to help you understand the original text.

Updated to version 4 on April 7th, 2023


Gap Assessment Tool to help you be ready for an MDSAP Audit.

This document contains all the questions an Auditing Organization can ask you to get MDSAP Certified.

This tool is divided on many tabs:

  • Management

  • Authorized Registration

  • Measurment, Analyze and Improvement

  • Advertisment and Advisory Reporting

  • Design and Development

  • Production and Service controls

  • Purchasing

I also included a table with all the regulations that are mentioned.

What else can we do so you are MDSAP certified?

This tool can help you to do the Gap Assessment yourself, but maybe you still need a confirmation that what you have performed is correct before your Certification Audit?

  • Easy Medical Device is proposing you to perform a Mock Inspection and test your system. This will then give you more confidence before the audit.
  • We can also train your team on how an Audit is executed and how to be prepared (before, during and after).
  • In the case you need more, please contact us at


There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.

You may also like…