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

Product Introduction System - Phase 4

 

Phase Description and Deliverables

Phase 4	Description	Example of Deliverables
Clinical & Pre-production	In this phase, validation and clinical studies will be performed to ensure product design, safety and efficacy. Activities such as design refinement, manufacturing process implementation and shelf-life testing are completed. Inventory for launch may be built in parallel with this stage if pre-approved. If clinical studies are not needed, Phases 4 & 5 may be combined pending approval.	Update Project Update risk assesment Update Operations plan Compete marketing plan Labeling approval Training Shelf-life testing Clinical builds and test reports Compete clinical studies Manufacturing Process Development, Tooling & Test Equipment Complete equipment IQ/OQ/PQ Manufacturing and inspection documents released Perform Regulatory Submissions Update Product Specification Reliability analysis
Approval of Clinical & Pre-production Phase (PHASE REVIEW)

To Previous Phase <-> To Next Phase

 

 

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

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