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

Product Introduction System - Phase 5

 


Phase Description and Deliverables

 Phase 5  Description  Example of Deliverables

 Market Release

Preparation and release for commercialization.

Manufacturing startup, inventory build and regulatory approval activities.

Product approved for human use at completion of this phase.

  • Manufacturing scaling
  • Regulatory approval
  • Labeling approval
  • Shelf-life testing complete
  • CPRA approval
  • Essential requirements checklist
  • Inventory build to forecast
  • Complete Technical File
  • Customer/marketing/sales training
  • Design History File review
  • Device Master Record review
  • Launch follow-up strategy complete

 

 Approval of Market Release 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.

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

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