The Medical Device Single Audit Programme (MDSAP) is the single biggest step towards global harmonisation of medical device regulation seen to date. This course details the main requirements of the regulations from Brazil, Australia, Canada and Japan and shows how these relate to ISO 13485, the EU MDR and the US Quality System Regulation (QSR). The course also deals with the MDSAP audit process and how to prepare for the MDSAP audit.
Note: All manufacturers who sell Medical Devices (class 2 or higher) into Canada from 1st January 2019 onwards must have their Quality Management Systems approved under the MDSAP programme. In order to meet this deadline, manufacturers will have to apply for MDSAP and successfully complete the audit programme in 2018.Collapse
9.00am to 3.00pm