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MDSAP certification

MDSAP - Medical Device Single Audit Program

By opting to use the MDSAP program, a medical device manufacturer calls upon the services of a recognized "auditing organization" (AO) to proceed with an evaluation of its Quality Management System (QMS) within the regulatory framework of 5 countries: Australia, Brazil, Canada, Japan, and the United States. MDSAP is mandatory in Canada since January 1st 2019.

What are the guiding principles behind MDSAP?

MDSAP is a voluntary program that is mandatory in Canada since January 1st 2019 for all Class II, III and IV medical devices (MD). A medical device manufacturer is eligible to call upon the services of a recognized "auditing organization" (AO) to proceed with an evaluation of its Quality Management System (QMS).

GMED has been authorized to conduct MDSAP audits. The certification contract is associated with a 3-year cycle. During each audit, the conformity of the company's quality management system with requirements stipulated under 5 regulations is assessed. The program's cornerstone is the "audit model", i.e. a document that serves to guide the auditing procedure. Nothing prevents this document from being used to actually develop the QMS, since it introduces a specific audit protocol and step-by-step approach to calculating audit time intervals.

Audit reports are submitted to the 5 regulatory authorities for use within the process of managing certification applications. Each country retains sovereignty and establishes how the program may be assimilated into its own regulatory framework.

More information on this program

 

For information on the GMED certification process, see the section Obtaining certification

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