Slide 4
Slide 4 text
“The purpose of MDSAP is to establish, conduct and command a single
audit program.” This allows a single audit of a medical device
manufacturer’s QMS which satisfies the requirements of multiple
regulatory jurisdictions. MDSAP Audits are conducted by Auditing
Organizations (AO), authorized by the participating Regulatory Authorities
(RA) to audit under MDSAP requirements. Accordingly, Medical Device
Single Audit Program (MDSAP) audit reports may be used by regulatory
authorities in lieu of their own inspection reports. The current MDSAP
program participants include: USA, Canada, Australia, Japan and Brazil.