What is a Medical Device Single Audit Program?

Medical Device Single Audit Program Definition

The medical device single audit program (MDSAP) is a program that allows for a single regulatory audit of a medical device manufacturer’s quality management system. This single audit satisfies the regulatory requirements of up to five different medical device markets (i.e., Australia, Brazil, Canada, Japan, United States).

FAQs

What is a medical device audit?

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How often is Mdsap audit?

Medical Device Single Audit Program content is being added. Stay tuned.

What is the difference between ISO 13485 and Mdsap?

Medical Device Single Audit Program content is being added. Stay tuned.

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