Workshop Details
Time - 9:00 am - 5:00 pm
Cost - CAD $645 + HST
Location - Online. Live. Interactive. Instructor Led
Abstract
Medical devices companies who develop their products and wish to sell them in the Canadian market, must acquire knowledge of the Canadian regulatory requirements for medical devices. Moreover, in order to be able to commercialize their products, the manufacturer/importer/distributer must be aware of the new regulatory framework that Health Canada has developed for these products.
The course will outline the main Canadian regulatory requirements for: - ITA submission
- Licensing application
- Establishment of Quality Management Systems
- Risk management
Who Should Attend
Personnel involved with: - Regulatory affairs
- Quality assurance
- Product development
- Manufacturing
- Clinical development
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