This phase translates the product defined in the POA into the feasibility through engineering prototypes.
Optimum Technologies program management insures the development process is followed including development of the Design History File (DHF), Engineering Requirement Document (ERD), Preliminary Risk Analysis, Regulatory Assessment, test reports, and appropriate design reviews.
Phase 1 Input
- Approved POA
- Approved preliminary PDP
- HFEP
- PRD
Phase 1 Outputs
- Initial DHF
- ERD
- Updated HFEP
- Preliminary Risk Analysis
- Preliminary Clinical Assessment provided by customer
- Regulatory Assessment(provided by OTI as requested)
- Works like prototypes
- Looks like prototypes
- Test reports
- Phase 1 Design Review Report
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