The best Quality System enhances your work without being a burden.
Customized design and setup of multi-tier scalable quality systems that meet or exceed FDA, ISO 13485, Health Canada and other world-wide regulatory agency requirements
- Quality System Manuals
- Quality System Procedures
Integrated systems for:
- Document control
- Process and product change control
- Non-conforming materials
- Corrective and Preventive Action
- Materials Review Board management
- Design and Device History Files
- Device Master Records
- Training for personnel at all levels
- Compliance Assessment