Phase I – Project Initiation

Deliverable Document Number Status

General product requirements / Conceptual Design
Initial feasibility testing
Market Assessment
Resource Requirements / Project Leader Assignment
Phase Review Record

Phase II – Design
Deliverable Document Number Status
Project Plan
Initial Risk Analysis
Product Requirements
Product Specification
Feasibility Test Summary
Patent Review
Regulatory and Clinical Strategy
Preliminary Manufacturing Plan
Design Review Record
Phase Review Record

Phase III – Verification &Validation

Deliverable Document Number Status
Product Requirements (updated)
Product Specification (updated)
Complete drawings, BOMs and component specs (index)
Design Verification Test Report
Design Validation Report
Biocompatibility Test Report
Shelf Life Test Report
Sterilization Validation Test Report
Package Integrity Validation Test Report
Product Name and model number
Preliminary and/or Investigational Use Only labeling
Intellectual Property Status
Risk Analysis (updated)
Project Plan (updated, with detailed transfer plan)
Pre-Clinical Review Record (if applicable)
Design Review Record
Phase Review Record

Phase IV – Design Transfer

Deliverable Document Number Status
Process Risk Analysis
Supplier Approval Summary
Process Equipment Qualification
Process Validation Report(s)
Production Quality Plan
Pre-Market Evaluation Report
Sales Plan
Forecast and Market Launch Plan
Regulatory Approvals
Real Time Aging Studies
Design Review Record
Phase Review Record