CMDR & Links to ISO 13485:2016
For quality managers, Regulatory Affairs personnel, internal auditors, and personnel involved in the implementation of the regulations:
We offer an updated one-day course that explains the requirements of the Canadian Medical Device Regulations (CMDR), its links to the standard ISO 13485:2016, and its links to the new Medical Device Single Audit Program (MDSAP)*. It also covers the various types of licences according to the class of medical device.
The course is presented by our associate consultant, a retired Health Canada professional who spent the last 20 years of his career in Health Canada’s Medical Devices Bureau.
For more details about the course, please visit the web page:
*Note: As of January 1, 2019, only MDSAP certificates will be accepted by Health Canada (in lieu of the previous CMDCAS certificates).