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 13485:2003. KEMA is a recognized registrar for the Canadian Medical Devices Conformity Assessment System (CMDCAS).

KEMA: 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 the Quality Management System as well as the product- related aspect in one combined audit. All regulatory auditing for medical devices via one service provider: KEMA. 
• 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 13485:2003 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. With this focus in mind, our auditors uncover ways to benefit you.        

For more information please contact us.