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.
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 AO, such as BSI, which has performed MDSAP audits worldwide and issued a significant number of global sites with MDSAP certifications; we are currently processing many more.
Find our more about MDSAP.