The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer's QMS which satisfies the requirements of multiple regulatory jurisdictions. Audits are conducted by Auditing Organizations (AO), such as BSI, authorized by the participating Regulatory Authorities (RA) to audit under MDSAP requirements.
The MDSAP is a way that medical device manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States.
A BSI MDSAP Audit can also be combined with assessment for CE and ISO 13485.
MDSAP audits can be performed by a recognized MDSAP Auditing Organisations (AO), such as BSI. BSI have been active through the MDSAP pilot phase and have now received significant numbers of applications for MDSAP, predominantly from world leading medical device manufacturers. BSI has performed over 200 MDSAP audits worldwide and issued a significant number of global sites with MDSAP certifications and we are currently processing many more.
FDA guidance on MDSAP can be accessed below:
FDA MDSAP Guidance Documents
View a comprehensive explanatory webinar from the FDA
FDA MDSAP Frequently Asked Questions