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.