The Development Phase involves the completion of the final design, the Design Verification, and preparing all of the information that will support a regulatory submission, where applicable. The R&D Engineering development will work in concert with the risk management systems to mitigate risk and perform Design Verification while following developed manufacturing processes and controls. Relevant data and information on similar and predicate projects which may impact design or manufacturing process should be reviewed and considered by the team, as appropriate. The Project Core Team will work to develop and do an initial release of the Device Master Record by the end of this phase. Final preparation work to support any clinical evaluations and detailed marketing planning is wrapped up in Phase 3 Development.