At the design qualification stage, we provide needed data points and information to verify and validate the product. The product should work like, look like and be made like a production product, as well as meet your original design intent (incorporating all requirements and inputs). The product we build for design qualification uses representative production parts.
High-level outputs
- Build production-like qualification product
- 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 product, we have completed all quality test reports. The Product Design team reviews and approves the qualification product, as well as all designs, plans, processes, paperwork, and other deliverables before moving on to the next phase.
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 product. We work closely with you to find the best solutions for your goals, and discuss key design, production, and process decisions and trade-offs.
