1992 -

Working Towards Harmonization in Medical Device Regulation

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Study Group 4 (SG4) - Auditing

Purpose of Study Group

SG3 is responsible for the task of examining existing quality system requirements in countries having developed device regulatory systems and identifying areas suitable for harmonization.

Purpose of Study Group

SG4 has been charged with the task of examining quality system auditing practices (initially among the founding members of the GHTF) and developing guidance documents laying harmonized principles for the medical device auditing process.

Study Group Details

• Study Group Chair
• Participants
• SG4 Work Plan: 2006 - 2008

Documents

• Proposed Documents - (for review & comments)
• Comments Template - (for use in providing comments on proposed documents)
• Final Documents
• Archived Documents
• Meeting Summaries

Updated 20 November 2007

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