The course will help you understand the rationale and the principles of the Canadian Medical Devices Regulations (CMDR). It will also help you implement the regulations in your organization, while focusing on your needs and building from your existing management system.
- Structure of the Canadian Medical Devices Regulations
- What is CMDCAS
- Classification of Medical Devices
- Device Licence and Establishment Licence
- Post market requirements, e.g. problem reporting, recalls, implant registration, etc.
- Controlling the value chain, i.e. suppliers and distributors
- Links between clauses of ISO 13485:2016 and sections of the CMDR
- Useful references and links
This one day course explains the requirements of the CMDR, their links to the Canadian Medical Devices Conformity Assessment System (CMDCAS) and to ISO 13485:2016. It also covers the various types of licences according to the class of medical device.
This course is intended for quality managers, for Regulatory Affairs personnel, for internal auditors, and for personnel involved in the implementation of the new Regulations.
Knowledge of ISO 13485:2003 or ISO 13485:2016 is recommended. An understanding of ISO 9001:2008 or, even better, 9001:2016 is very useful.
This course is at its best when presented in-house. Call us or e-mail for a quote.
Certificate of attendance of 7 hours.