This course is available for virtual delivery – please contact us for further details
(1 face-to-face training day typically translates into 2 to 4 virtual sessions per day, this is determined by the specific course content. Number of sessions and specific session times will be confirmed in advance of course delivery.)
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
As we have seen in the first of our blogs submitted by John Lafferty, MDSAP is the Medical Device Single Audit Programme which consists of a single Quality Man...