Phoenix Ambulatory Blood Pressure Monitor Project
Sub-project: Regulatory Approval - Processes

Product Introduction System - Phase 3

 


Phase Description and Deliverables

 Phase 3  Description  Example of Deliverables & Activities
 Development  This phase represents product development activities including design, prototyping, systems integration, verification and validation, and product release to manufacturing.
  • Released product specification (alpha rev.)
  • Manufacturing and Quality documents
  • Environmental assessment
  • Risk analysis (Human factors, Design FMECA, FTA, etc.)
  • Design for manufacturing & service
  • Design verification plan, test executions and reports
  • Initial Shelf-life testing
  • Animal testing
  • Clinical feasibility
  • Identify and qualify suppliers
  • Update Intellectual Property analysis
  • Design review
  • Phase 4 cost/scope
  • Essential requirement checklist
  • Process FMECA
  • Product & Process validation
  • Initiate clinical planning
  • Product Release to Manufacturing
  • Update & Review all pertinant living documents

 

 Approval of Development Phase (PHASE REVIEW)

To Previous Phase <-> To Next Phase

 

 

About This Page

This page is maintained by Ellis S. Nolley. It was last updated on 28 October 2004.

The author(s) provide this information as a public service, and agree to place any novel and useful inventions disclosed herein into the public domain. They are not aware that this material infringes on the patent, copyright, trademark or trade secret rights of others. However, there is a possibility that such infringement may exist without their knowledge. The user assumes all responsibility for determining if this information infringes on the intellectual property rights of others before applying it to products or services.

Copyright (C) 2004 Ellis S. Nolley. Copying and distribution of this page is permitted in any medium, provided this notice is preserved.

Back to the Phoenix Home Page