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

 

Project Description

The purpose of the regulatory approval project is to identify requirements for regulatory approvals, and develop documents and processes to satisfy them. Geographic regions, such as the US and Europe, have specific requirements and approval processes that must be satisfied to use blood pressure monitors on people in their regions. We will develop a complete design sufficient for manufacturing, and our process and documentation combined with that of manufacturers must be sufficient to satisfy the regulatory approval requirements. We will validate this with a manufacturer by taking the monitor through an approval process so that the Halberg Chronobiology Center and other organizations can use the monitor in the Phoenix Measurement Program, in the Phoenix Clinical Program, and by other organizations in their services and products.


Project Deliverables

 

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

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