This course provides a comprehensive overview of Canada’s medical device regulatory framework, including both pre-market and post-market requirements.
This two-hour overview covers the changes and key aspects of the regulations as well as instruction on the way Canada is utilizing MDSAP.
By the end of this course, you should:
- Identify the regulatory framework for medical devices.
- Determine the correct classification for medical devices.
- Understand how Canada utilizes the Medical Device Single Audit Program (MDSAP).
- Understand the premarket pathway and requirements for medical devices.
- Understand the Quality Management System regulations required to market a medical device.
- Understand the post-market requirements for medical devices.
By completing/passing this course, you will attain the certificate Medical Device Certificate
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