Viewed as a set of effective tools, rather than a regulatory burden, the Quality Management System will help you efficiently navigate the complex landscape of medical device development and management:
- Procedures, Instructions, Templates and Forms for an effective and audit ready QMS
- The trace matrix approach to managing critical information through the product life-cycle
- Device History File development, including Product Verification and Validation
- Risk Management per ISO 14971
- Test Method development and validation
- Process development and Process Validation
- Device Master Record development and maintenance
- Device History Record structure and alignment
- Analysis of feeder system data and CAPA