![]() Management systems for medical device manufacturersCanadian regulations require that medical devices be manufactured under a certified quality management system that meets the criteria of the international standard ISO 13485. The corresponding Canadian national standard is CAN/CSA-ISO 13485. Health Canada's Therapeutic Products Directorate The Standards Council of Canada accredits organizations that certify the management systems of medical device manufacturers. Under CMDCAS, only certification bodies acredited by the Standards Council of Canada are eligible to certify a medical device manufacturer’s management system. | ![]() Within this section:
Specific programs:
Related links: |