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. 

Contact Us