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: 2016 and the US QSR and how to audit against them.
All manufacturers who sell Medical Devices (class 2 or higher) into Canada from 1st January 2019 onwards must have their Quality Management Systems (QMS) 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. The Auditing Organizations that approve Medical Device manufacturers under MDSAP will expect to see evidence that the QMS has been audited, by trained auditors, against the MDSAP requirements.
This two day course provides detailed training in developing the skills necessary to be an effective MDSAP internal auditor.