ISO 13485 Quality Management System

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.

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives and Regulations.

Although ISO 13485 certification is not mandatory for CE marking medical devices under the European Medical Device Directives (AIMDD, MDD, IVDD), it is harmonized, which allows the presumption of conformity to the Directives.

ISO 13485 is the best internationally accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices under European Directives and Regulations and UKCA marking medical devices under the UK MDR 2002. ISO 13485:2016 remains a state-of-the-art document. BSI, as one of the leading EU notified bodies and UK approved bodies, can verify medical device manufacturers’ selection of the most efficient conformity assessment routes to achieve CE and UKCA marking.