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

 

Description

This section describes the regulatory approval documents that Phoenix will provide. FDA has provided a Quality Systems Manual guide for small organizations at www.fda.gov/cdrh/dsma/gmpman.html and a Quality Systems inspection guide for their inspectors at www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm.

Topics

• Premarket Notification [510(k)] Submission
• Quality System Manual
• QS regulation (QSR) records
  • design history files
  • device master records
  • device history records
  • maintenance schedules and records
  • complaint files and failed device/component files
  • audit reports
  • distribution records
  • personnel training records

 

 

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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