Canadian Medical Device Regulations (CMDR) and CMDCAS, the conformity assessment system, are the prime elements of regulatory compliance and certification in Canada.
We know the Canadian regulatory compliance process, the costs, what works, what does not work and how to effectively interact with testing laboratories, CMDCAS registrars and Health Canada regulatory compliance officials.
With Horizon Phoenix as your consulting partner you will quickly navigate through:
- Self declaration of product certification and conformity (if applicable)
- Family or product grouping that saves time and money
- Regulatory compliance routes (including options, if applicable)
- Safety and Effectiveness requirements
- Using recognized standards to demonstrate regulatory conformance
- Labels and instructions for use
- Product certification testing
- Assembly Technical (STED) Files
- Risk Assessment and risk management
- Declaration of Conformity
- ISO 13485 quality management systems including Canadian regulatory compliance deviations, and
- Preparing for CMDCAS assessments.
Ask us how to enter this market!
