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

 

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.

Contents

• Regulatory Approval Project Plan
• Background Information
  • Requirements
  • Processes
  • Documents
    

 

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.

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