ISO13485 under Canadian Medical Device Regulations
Medical device manufacturers who want to access the Canadian market must, as part of the requirements to obtain and maintain a medical device license from Health Canada, be registered in accordance to ISO 13485 under the CMDCAS requirements by a Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrar.
Through the cooperation between Presafe´s subsidiary DGM Denmark A/S and SAI Global, which is accredited by Canada's National Accreditation Body, the Standards Council of Canada (SCC), we can:
- Facilitate Canadian and US customers’ access to the EU market by offering CE-marking;
- Help manufacturers secure a medical device license from Health Canada, required for obtaining ISO13485 management system certification under Canadian Medical Device Regulations (CMDCAS);
- Carry out integrated audits combining EN ISO 13485 and ISO 13485 under the CMDCAS requirements plus the Medical Device Directives thanks to our CMDCAS qualified and highly experiences auditors.