Under Canada’s Medical Devices Regulations (MDR), medical device manufacturers must prove that the devices they market or sell are safe, effective and meet quality standards. Other than the lowest risk (Class I) items, all Medical Devices and In Vitro Diagnostic Devices (IVDDs) are required to meet specific quality criteria based on standards developed by the International Organization for Standardization (ISO).
To verify these requirements, manufacturers must contract with an independent registrar who is accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and is recognized by Health Canada (the Canadian Ministry of Health).
A registrar confirms a manufacturer's quality management system operates in compliance with a Canadian version of ISO 13485 standards by assessing procedures and product management in the following main topic areas:
- Document Control
- Management Responsibility
- Resource Management
- Realization of the Product
- Monitoring, Measurement and Improvement
Working with an experienced and recognized registrar, such as LNE/G-MED, can be one of your most important steps to ensure a smooth, efficient audit process, obtain valuable feedback on your quality processes and convey credibility to your customers, business partners and regulators.