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ISO Certification
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Health Canada requires medical device manufacturers to use a quality system certificate as evidence of compliance to the appropriate regulatory quality system requirement. Health Canada will only accept quality system certificates that have been issued by special third party auditing organizations called Canadian Medical Devices Conformity Assessment System (CMDCAS) recognized registrars.
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The Medical Devices Regulations require class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system requirements for Class I medical devices. These quality system requirements came into force on January 1, 2003.
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Innovatek Medical Inc. has been certified to CAN/CSA 13485:2003 Quality Management System.
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What are CAN/CSA ISO 13485:2003?
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CAN/CSA ISO 13485:2003 is the updated Quality Management System adopted in 2003 to replace ISO 13488 and ISO 13485 standards that provide specific requirements for the application of ISO 9000 to the medical devices industry.
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This standard helps to ensure the consistent application of quality requirements in the medical devices and in-vitro diagnostic devices industry. It is being applied as part of the regulatory regime for medical devices in a number of countries.
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In Canada, CAN/ISO ISO 13485:2003 forms the basis for the new Canadian Medical Devices Conformity Assessment System (CMDCAS). Only registrars recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR) can certify companies to this standard.
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What is CMDCAS?
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Canada’s Medical Devices Regulations, which took effect on January 1, 2003, require certain types of medical devices to be manufactured under a quality system that meets the requirements of CAN/CSA ISO 13485:2003. The Canadian Medical Devices Conformity Assessment System (CMDCAS) has been developed by Health Canada and the Standards Council to implement these new regulations.
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As part of the system, the Standards Council will qualify accredited quality management system registration bodies to register manufacturers' quality management systems to the appropriate standards.
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