Design Process
Project Analysis
- Legal Assessment of Intellectual Property
- Defining Design Strategy (Regulatory, Marketing, Transfer to Manufacturing)
- Scheduling Design Process
Feasibility Phase
- Formalizing Design Input Requirements
- Planning of Design Process (QA, Regulatory, Hazard Analysis, Transfer to Manufacturing)
- Prototype Build and Test
Design and Development
- Design Phases with Milestone Reviews
- Updating Design Input Requirements and Relevant Plans
- Following Rules of Design Control System to Create Design History Files Delivered to the Customer
Evaluation
- Validation and Verification
Release to Market
- Working with Customer and CM on Transfer to Manufacturing
