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Quality systems, business processes and the skills your people need to make it all work.
Live, instructor-led, remote training covering the knowledge required to successfully host an MDSAP audit. Based on the MDSAP G0002.1.0004 Companion Document with emphasis on MDSAP processes and their associated audit tasks.
Duration: 8 Hours Training plus 1/2 hour mid-day break
The Medical Device Single Audit Program (MDSAP) is an international initiative to implement a program through which a single audit of a medical device manufacturer will be accepted by multiple regulators to address QMS/GMP requirements. Participating regulatory authorities include Australia, Brazil, Canada, Japan and the USA.
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.
None. This is an introductory course. (Previous experience working within an ISO 13485 quality management system and/or a medical device quality environment is helpful, but not required.)
Understanding Requirements, Auditing Skills
Medical Devices (ISO 13485, ISO 14971)
|Open or Dedicated||
Open Enrolment, Dedicated Session
Mar 11, 2024 – 9:00am to 5:30pm ET
Monday: 9am-5:30pm EST
Tuesday: 9am-5:30pm EST
Wednesday: 9am-5:30pm EST
Thursday: 9am-5:30pm EST
Friday: 9am-5:30pm EST