Medical Device Single Audit Program

What is a Medical Device Single Audit Program audit?

Through MDSAP, medical device manufacturers need only to be audited once in order to comply with the standard and regulatory requirements of up to five different medical device markets.

These are; Autralia, Brazil, Canada, Japan and United States. Audits are conducted by Auditing Organizations (AO), such as BSI, and authorized by MDSAP member Regulatory Authorities (RA). BSI is an Auditing Organization for MDSAP. Here at BSI, we also offer MDSAP in combination with CE, UKCA, ISO 13485 and ISO 9001 assessments. We have been active since MDSAP's inception pilot phase and have already completed a significant number of MDSAP audits, predominantly for world-leading medical device manufacturers and SMEs.

Medical Device Single Audit Program process

What are the benefits of MDSAP?

A Single Audit by Auditing Organizations would:

minimize medical device manufacturer disruptions due to multiple regulatory audits
provide reliable audit schedules (agenda with opening and completion dates)
benefit patient health and patient access with ease of entry to multiple markets
leverage regulatory resources
incorporate ISO 13485 assessment
meet regulatory requirements of Australia, Brazil, Canada, Japan and the US
reduce time and resources dealing with findings from multiple audits
reduce the cost of audits in comparison to independent audits
improve transparencies in the industry

MDSAP resources to support you

A BSI MDSAP audit can also be combined with assessment for CE and ISO 13485.
Download the MDSAP brochure >
Critical update on Medical Device Single Audit Program (MDSAP)
Watch on demand MDSAP webinar >
Medical Device Single Audit Program (MDSAP): Fundamentals and Readiness
Book MDSAP training >
Responsibilities for medical device vigilance reporting
Download vigilance whitepaper >

BSI has been a participant of the Medical Device Single Audit Program since the pilot of the program and has been able to certify manufacturers across the globe through this efficient audit process. BSI is proud of the growth the program has seen these past years and are looking forward to the continued expansion of the program. The MDSAP Affiliate program now allows manufacturers to utilize their MDSAP Certificate and Reports to aid in obtaining market access not just in the five MDSAP Member countries, but also in the growing pool of MDSAP Affiliate Member countries. It is showing that it truly is a Single Audit Program for the certification of our clients Quality Management Systems.

Morgan Quandt, Global MDSAP Manager