Medical Devices and Regulatory Affairs

• ​ISO 13485: 2016 and MDSAP medical device quality system documentation, implementation, training and internal audit services.

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• Documentation and Implementation of Canadian Medical Device Regulations- Part 1 SOR 98/282.

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• Documentation and implementation of CE Marking for medical devices, EU MDR 2017/745

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• Documentation and implementation of FDA QSR 21 CFR Part 820 requirements.

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• Documentation and implementation of Japan’s Pharmaceutical Affairs Law (JPAL) for medical devices.

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• Implementation of Risk management for medical devices ISO 14971:2019.

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• Submissions and amendments for medical device licenses (MDL) to Health Canada.

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• Submissions and amendments for medical device establishment licenses (MDEL) to Health Canada

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• License submissions and amendments for natural health products (NHP) to Health Canada.