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How to do a gap analysis for MDSAP requirements

It's already hard enough to comply to one directive or regulation, but most of the time, you don't focus on only one market. And quickly you need to comply to several legislations. This causes a significant burden on organizations.

Also regulators are aware of this and 5 countries decided to work together to develop a single audit program, called Medical Device Single Audit Program (MDSAP).

The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets for their organization and Quality Management System: Australia, Brazil, Canada, Japan and the United States.

So how can you make sure you comply to the different requirements from different regions? Not only for what your quality management system is concerned, but as well other requirements.


In MatrixQMS, we allow you to make a gap analysis between your processes and the requirements of different legislations and standards. 

MatrixQMS has the possibility to integrate all requirements from standards and regulations. These requirements can be linked to your processes to show how you fulfill them. 

While doing the exercise of linking the requirements with the different processes, you can also identify possible gaps.

Using a Trace Matrix, you can show how you comply to each and every requirement in a very clear and transparent way. This is useful both within your organization as well as for audit purposes.


Interested in a demo on how to show compliance to MDSAP or other regulatory requirements using MatrixQMS? Don't hesitate to contact us!

About the Author
Ann Vankrunkelsven
RA/QA Manager