Docusys Corporation Engineering Solutions
 Medical Devices & Regulatory Affairs

Services include:

  1. ISO 13485: 2003 medical device quality system documentation, implementation, training and internal audit services
  2. Documentation and Implementation of Canadian Medical Device Regulations
  3. Documentation and implementation of CE Marking for medical devices, MDD 93/42/EEC
  4. Documentation and implementation of FDA requirements.
  5. Documentation and implementation of Japan’s Pharmaceutical Affairs Law for medical devices.
  6. Implementation of Risk management for medical devices ISO 14971:2007
  7. License submissions and amendments for medical devices to Health Canada
  8. License submissions and amendments for natural health products (NHP) to Health Canada.

Outsourcing Quality Management & Regulatory Affairs Tasks

Aerospace Quality Management Systems

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