Medical Device Single Audit Program (MDSAP)

Virtual Learning

April 7 – 8, 2022

Course Overview

This course is 2 days. Students will understand the requirements of MDSAP and how Australia’s TGA, Brazil’s ANVISA, Canada’s HC, Japan’s PMDA and the United States’ FDA will implement the program moving from the pilot to the operational phase. Students will also understand the new regulatory QMS audit findings/non-conformance grading system and what grades trigger regulatory follow-up and comprehend the regulatory transitions for MDSAP and discuss strategies on how companies can optimize alignment.

Who Should Attend

This course is vital for any medical device quality professional to include quality directors, manager, engineers and auditors responsible for implementing a quality management system in accordance with ISO 13485:2016 and plan to undergo an MDSAP audit.

Price: $1200.00