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Medical Device Single Audit (MDSAP)

Fulfil Compliance Requirements of the Medical Device Single Audit Program (MDSAP)

DEKRA’s specialists check and assess the level of compliance of customers’ management systems according to the Medical Device Single Audit Program (MDSAP).

The benefits of Medical Device Single Audit (MDSAP)

  • Fulfil all the compliance requirements in the Medical Device Single Audit Program (MDSAP)

  • Avoids duplication of audit by the participating regulatory authorities, thereby accelerating market entry

Medical Device Single Audit Program (MDSAP)

About Medical Device Single Audit (MDSAP)

DEKRA is a recognised MDSAP auditing organisation and also one of the largest Notified Bodies in the world for companies involved in the design, manufacturing, and distribution of medical devices. Our specialists check and assess the compliancy of our customers’ management systems according to the Medical Device Single Audit Program (MDSAP), which is designed to allow a single audit for medical device manufacturers to show compliance with the regulatory requirements that is accepted n multiple regulatory jurisdictions.

Compliance with the MDSAP can accelerate entry of products into the participating jurisdictions and reduce the number of regulatory audits a manufacturer receives each year. Currently, the following countries participate in the program: Australia, Brazil, Canada, Japan and the USA, with a number of other countries reviewing their participation in the scheme. Today, major observers of the scheme include China and the EU.

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