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

 

Description

This section describes the regulatory approval processes that apply to Phoenix.

Topics

• Quality system, especially:
  • Design Controls
  • Document controls.
  • Purchasing controls.
  • Identification and Traceability
  • Production and Process Controls
  • Records
  • Statistical Techniques
• Electronic Records, 21 CFR Part 11
• Phoenix Product Introduction System (*NEW*)

 

 

About This Page

This page is maintained by Ellis S. Nolley. It was last updated on 7 November 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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