How are regulatory changes incorporated into the MDSAP?

MDSAP Audit Approach documents are periodically revised to reflect any changes in regulatory requirements. Accordingly, the impacted MDSAP training will be updated. The IMDRF MDSAP WG N3 document requires “The Auditing Organizations to participate in any regulatory coordination group established for the purpose of keeping the Auditing Organization’s personnel current on medical device legislation, guidance documents, standards, and best practice documents adopted in the applicable regulatory systems.” (N3 – Clause 6.1.3). Further information on RA specific requirements is available here.