Quality Assurance

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