Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will automatically be cleared or approved by FDA. Any medical device company considering MDSAP should be familiar with what the program is and is not.

In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Danny Kroo, a medical device consultant and sub-contract lead auditor for several registrars that provides quality management system (QMS) and regulatory affairs services.

Listen to Jon, Etienne, and Danny as they help to align expectations about the MDSAP journey so manufacturers can understand both how program works and how it should be leveraged from a regulatory strategy standpoint.

Some of the highlights of this episode include:

The reaction to requiring MDSAP certification to access and sell medical devices in Canada created price increases and smaller companies were unable to justify changing the notified body or auditing organization.
MDSAP provided opportunities and benefitted some distributors by getting and using technical files and documents provided by the original manufacturers.
MDSAP satisfies the need for some countries, including the United States and Canada, but some companies in other countries think the approach takes too much time, money, and resources for a single audit.
MDSAP involves assigned tasks, questions, and interpretations for seven processes during the single audit. For ISO 13485 certification, there is variability and jurisdictions are not always asked the same questions by all auditors.
There should not be any surprises during an audit if companies conform to requirements outlined in regulatory resources, such as guidance documents, FAQs, procedures and forms.
The FDA’s MDSAP model and approach should be an easy process, but it depends on your company and the level of maturity of your quality system.
Easily find and retrieve tribal knowledge by capturing and organizing it in your company’s quality system in the event of an audit.

Memorable quotes from Danny Kroo:

“If you do want to sell into a country, especially Canada, you need to have an MDSAP certificate.”

“It made things more expensive and it made the barriers for entry much higher.”

“What is the purpose of an audit? It’s to see if you conform to the requirements.”

“It should be an easy process. It isn’t so easy because some companies’ systems are mature and they go through it quite easily and others are not. It depends on your company, it depends on the level of maturity of your quality system.”

“A certain level of tribal knowledge is still there because you have the system.”

Links:

FDA - Medical Device Single Audit Program (MDSAP)

FDA - MDSAP Audit Approach

FDA - MDSAP Audit Procedures and Forms

ISO 9001

ISO 13485:2016

European Union Medical Device Regulation (EU MDR)

Health Canada

Navigating the Medical Device Single Audit Program (MDSAP)

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Navigating the Medical Device Single Audit Program (MDSAP)