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CMDCAS QMS Requirements
 
You will need to establish and maintain a Medical Quality Management System compliant with ISO 13485:2003 and with the quality system requirements of the Medical Devices Regulations (MDR).
A Registrar accredited to the Canadian Medical Devices Conformity Assessment System (CMDCAS) scope must register the Medical Quality Management System before you apply for a medical device license.
The scope of your Medical Devices Regulations (MDR) compliant Medical Quality Management System depends on the classification of your device.
 
Arazy Group –Quality Management System Requirements – CMDCAS regulation – ISO13485
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