Solutions:

As authorized and practicing CMDCAS auditors RA/QA International can be an invaluable resource in enabling you to achieve ISO 13485 certification. We also work with manufacturers on device classifications and Health Canada licensing. See the CAPA section for reference to Canadian Problem Reporting.
Contact us to discuss:

Assistance with device classifications and regulatory license submissions to Health Canada for all device categories

Half-day and full-day training to ensure understanding of CMDCAS and Canadian Medical Device Regulations as applicable to your organization

Documentation analysis, gap analysis and corrective actions to ensure CMDCAS compliance and certification readiness

Internal auditing of your facility to ensure independence and ongoing compliance

In addition, you may want to visit the following URL:

http://www.scc.ca/standards/cmdcas/index_e.html