Design & Development
During these phases, design concepts are translated into fully engineered design solutions that are rigorously tested to confirm final design. This transition to detailed engineering draws heavily on the multi-disciplinary makeup of our program teams and agile development process.
Minimizing risk in the design effort is required by ISO 14971 & adopted practice at Ximedica
Core to the design development effort, user needs are translated into measurable, finite specifications that result in a product that is safe and efficacious. A risk evaluation and mitigation strategy applied early and throughout product development provides assurances that the design effort will minimize design, process and use-errors.
Robust test methods reaffirm design decisions
During verification a product undergoes rigorous testing to verify that function, reliability, usability, and safety meet specifications. Core to this activity are statistical techniques to determine proper sample sizes based on risk and measurement system analysis. Utilizing these techniques along with independent reviewers ensures test methods are robust and validated.
Design & development outcomes
- SDS, Risk Management, UFMEA
- Tooling purchase & debug
- Pilot build
- Traceability matrix
- Final Master verification plan