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加拿大CMDR質量體系認證
Canadian Medical Device Regulations (CMDR) Introduction
If your company sells medical devices in Canada, the company is required to maintain a quality management system compliant with the Canadian Medical Device Regulations (MDR). This system is based on ISO 13485 standard and includes additional specific to Canada requirements.
Our GHTF Services Include:
We can help medical device and IVD companies meet the Canadian Medical Device Regulations (CMDR) so they can gain access to this market. We can help you implement or modify an ISO 13485:2003 quality system and complete your Medical Device Licence application so you are in full compliance with the Canadian Medical Device Regulations (CMDR).
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