Medical Devices & Regulatory Affairs
- ISO 13485: 2003 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.
Outsourcing Quality Management & Regulatory Affairs Tasks
Aerospace Quality Management Systems