This phase is the iterative process of designing, constructing, and testing of engineering prototypes to achieve the functionality defined in the PRD.
The PDP is updated. The PRD individual requirements are traceably translated into the ERD, system and subsystem requirements specifications, and the Systems Requirements Specification (SRS). Detailed design, verification and software validation activities are conducted and documented until all requirements have been traceably satisfied.
Phase 2 Inputs
- 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
- Updated PDP
Phase 2 Outputs
- Functioning Engineering Prototypes (looks-like, works-like)
- Updated DHF
- Test Plans
- Test Report
- Trace Matrices
- Verification Report
- Updated Regulatory Assessment(if OTI is managing submission)
- Completed Risk Analysis
- Phase 2 Design Review Report
- Updated PDP
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