Firm Ready to Perform ISO 13485 Audits
To apply for or maintain a valid license for Class II, Class III, or Class IV medical devices, all manufacturers are required by Health Canada to register to ISO 13485:2003 under CMDCAS by March 15, 2006. Audits for ISO 13485:2003 can now be performed by QMI, Cleveland, (qmi.com). Accreditation by the Standard Council of Canada (SCC) lets QMI offer registrations to ISO 13485:2003 under CMDCAS (Canadian Medical Devices Conformity Assessment System), in addition to ISO 13485:1996 and ISO 13488:1996.
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