1992 -

Working Towards Harmonization
in Medical Device Regulation

Steering Committee

Meetings & Training

GHTF > Study Groups > Study Group 4 (SG4) > SG4 - Final Documents

SG4 - Final Documents

Title	Description	Posted Date	Size	Comments To
SG4/N33R16:2007 PDF Word	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports	19 November 2007	11 pages
SG4/N30R20:2006 PDF Word	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy	31 August 2006	33 pages
SG4 (99) 28 PDF Word	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements	30 December 1999 *Reposted: 30 October 2000	31 pages, 131Kb-PDF 138Kb-Word
SG4 (99) 14 PDF Word	Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1)	30 December 1999 *Reposted: 30 October 2000	1 page, 36Kb-PDF 55Kb-Word
SG4 (00) 3 PDF Word	Training Requirements for Auditors (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 2)	15 March 2000 *Reposted: 30 October 2000	6 pages, 42Kb-PDF 73Kb-Word
SG4-N(99) 24R3 PDF Word	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit Documentation (Clause 5.7)	12 July 2002	6 pages, 259Kb-PDF 58Kb-Word
SG4-N26R1:2001 PDF Wo rd	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 6 Observed Audits of Conformity Assessment Bodies	10 August 2001	8 pages, 121Kb-PDF 89Kb-Word

*Reposted dates indicate when the document was reposted with a standard format cover sheet.

Updated 20 November 2007

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