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?

A medical device audit is a systematic, documented procedure that aims to gather data and determine whether devices are manufactured in accordance with regulatory requirements and good manufacturing practices. They might be carried out on an announced or unannounced basis by notified organizations and government authorities.

*Source: https://www.cognidox.com

How often does an MDSAP audit take place?

The MDSAP allows medical device manufacturers to be assessed once for conformity with the regulatory and standard requirements of up to five separate medical device markets: Australia, Brazil, Canada, Japan, and the United States.

*Source: https://www.fda.gov

What is the difference between ISO 13485 and MDSAP?

ISO 13485 and MDSAP are two separate programs with comparable specifications, but they are not interchangeable. MDSAP has the stricter criteria of the two, and organizations that are already certified to ISO 13485 will experience an increase of audit days once they pursue MDSAP certification.

*Source: https://www.qmii.com

The Cost
of
Mistakes

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.