The Medical Device Single Audit Program (MDSAP) is an international program through which a single audit of a medical device manufacturer that will be accepted by multiple regulators to address QMS/GMP requirements. Participating regulatory authorities include Australia, Brazil, Canada, Japan and the USA.
Medical Device Single Audit Program (MDSAP) Fundamentals
This 1-day course is relevant for any size organization selling medical devices into the participating regions. It will help you to determine if your own Quality Management System processes are consistent with the requirements of the MDSAP audit model and assist in preparing you to host an MDSAP audit.