Medical Devices & Regulatory Affairs

Services include:

  • ISO 13485: 2016 medical device quality system documentation, implementation, training and internal audit services.
  • Documentation and Implementation of Canadian Medical Device Regulations.
  • Documentation and implementation of CE Marking for medical devices, MDD 93/42/EEC.
  • Documentation and implementation of FDA requirements.
  • Documentation and implementation of Japan’s Pharmaceutical Affairs Law for medical devices.
  • Implementation of Risk management for medical devices ISO 14971:2007.
  • License submissions and amendments for medical devices to Health Canada.
  • License submissions and amendments for natural health products (NHP) to Health Canada.
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