CMDCAS Program.
Access to the Canadian medical market
The regulations for medical devices in Canada require that your medical devices be manufactured under a registered Quality Management System. Your Quality Management System must correspond with CAN/CSA ISO 13485. KEMA is a recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS).
All regulatory audits via one service provider
When the regulations require that your medical devices are manufactured under a registered quality management system, KEMA is one of a select group of registrars that can provide this as a stand-alone certification or in combination with others. KEMA’s 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 KEMA.
- KEMA is able to certify your Quality Management System as well as the product related aspect in one combined audit
- KEMA knows your organization, quality system, and products from CE auditing
- CE certification audits and the CAN/CSA ISO 13485:2003 certification are integrated, thus saving overall audit time in your facility
- The regulatory knowledge of the Notified Body auditors will be useful for the 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.
More information? Contact us.
< back to Medical services