CMDCAS programme

CMDCAS programme

Providing access to the Canadian medical market

The regulations for medical devices in Canada require all medical devices to be manufactured under a registered Quality Management System (QMS). Your QMS must therefore comply with CAN/CSA ISO 13485.

DEKRA is a recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS). What’s more, with us you can arrange to have all of your regulatory audits provided by a single provider. If your medical devices need to be manufactured under a registered quality management system, DEKRA is one of a select group of registrars that can provide this as a stand-alone certification or in combination with others. Our Notified Body auditor, who is also your contact for the Medical Directives (AIMDD, MDD, IVDD) CE certification, will be the lead auditor.

There are clear advantages for selecting DEKRA.

  • We can certify your QMS and product-related aspects in a single combined audit
  • Thanks to our CE auditing role, we know your organization, quality system, and products
  • CE certification audits and CAN/CSA ISO 13485 certification can be integrated, saving overall auditing time (and money)
  • The regulatory knowledge of the Notified Body auditors is a distinct advantage during CAN/CSA ISO 13485 certification
  • You have the assurance that your certificate has been issued by one of the leading Notified Bodies worldwide
  • In our unique approach to certification, we customize the process in every possible way, providing a service that meets your individual requirements.