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Medical Devices and Regulatory Affairs

Our Services Include:
  • ​ISO 13485: 2016 and MDSAP medical device quality system documentation, implementation, training and internal audit services.
  • Documentation and Implementation of Canadian Medical Device Regulations- Part 1 SOR 98/282.
  • Documentation and implementation of CE Marking for medical devices, EU MDR 2017/745
  • Documentation and implementation of FDA QSR 21 CFR Part 820 requirements.
  • Documentation and implementation of Japan’s Pharmaceutical Affairs Law (JPAL) for medical devices.
  • Implementation of Risk management for medical devices ISO 14971:2019.
  • Submissions and amendments for medical device licenses (MDL) to Health Canada.
  • Submissions and amendments for medical device establishment licenses (MDEL) to Health Canada
  • License submissions and amendments for natural health products (NHP) to Health Canada.
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Image by Jaron Nix
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Questions?

To discuss your requirements, please do not hesitate to contact us.