At the design qualification stage, we provide needed data points and information to verify and validate the component. The component should work like, look like and be made like a production component, as well as meet your original design intent (incorporating all requirements and inputs). The component we build for design qualification uses representative production parts.
High-level outputs
- Build production-like qualification component
- Test the design and prepare verification testing reports
- Complete the device master record (DMR)
- Execute the biocompatibility strategy
- Revise and finalize the complete risk management plan
- Conduct design failure mode effects analysis (FMEA)
- Review the instructions for use (IFU)
- Test biocompatibility
- Validate packaging and sterilization
Results
Following comprehensive testing of the production-like qualification component, we have completed all quality test reports. At this point, with all designs, plans, processes, and paperwork prepared and signed off by the Component Design team, the component is ready for production.
Tools
We use a detailed design validation process—following established standard operating procedures and ISO requirements—to consider and plan for every requirement for manufacturing, packaging, and using your component. We work closely with you to find the best solutions for your goals, and discuss key design, production, and process decisions and trade-offs.
