Phase 1 Documents – Analysis

DocumentDomain
Market AnalysisPlanning
Financial ReviewPlanning
Legal/IP AnalysisPlanning
Regulatory Strategy (Rev00)Strategy
Reimbursement Strategy (Rev00)Planning
Clinical Strategy (Rev00)Planning
Design and Development Plan (Rev00)Planning
Software Development Plan (Rev00)Planning
Risk Management PlanRisk
Preliminary Hazard AnalysisRisk
Customer Requirements Document (Rev00)Requirements
Design Review (Design Inputs)Review
Phase Review (Phase I: Analysis)Review