The MDSAP is a recognised standard jointly developed, managed, and monitored by several countries (see below) to provide regulatory quality management audits for medical device manufacturers. Audits are conducted by specialised and authorised organisations, which aims to provide a more uniform and consistent approach to audits.
The main objectives of the MDSAP are:
- To identify systemic non-conformities in the Quality Management System (QMS).
- To conduct audits in a standardised manner.
- To conduct audits in an efficient and meaningful manner that also considers process-related interactions.
The participating countries are the USA, Japan, Canada, Brazil, and Australia. Argentina, South Korea, and Singapore are listed as affiliate members. The European Union (EU), Great Britain and the World Health Organisation (WHO) participate as observers.
