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GHTF/SG4/N28R4:2008
FINAL DOCUMENT
Title:  Guidelines for Regulatory Auditing of
Quality Management Systems of Medical
Device Manufacturers –
Part 1: General Requirements
Authoring Group:  GHTF Study Group 4
Endorsed by:  The Global Harmonization Task Force
Date:  August 27, 2008
      Dr. Roland Rotter, GHTF Chair
The document herein was produced by the Global Harmonization Task Force, which is comprised of
representatives from medical device regulatory agencies and the regulated industry. The document is
intended to provide non-binding guidance for use in the regulation of medical devices, and has been
subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution or use of this document; however, incorporation
of this document, in part or in whole, into any other document, or its translation into languages other than
English, does not convey or represent an endorsement of any kind by the Global Harmonization Task
Force.
Copyright (c) 2000 by the Global Harmonization Task Force

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