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.
Docusys Corporation 