A comprehensive overview of Canada's Medical Device regulatory framework, including both Premarket AND Postmarket requirements. Learn what it takes to bring a product to the Canadian market and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how Canada is utilizing MDSAP. Includes competency assessments to provide documented evidence for the training requirements of ISO 13485:2016, the International Quality Management System Standard.
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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