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Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 4 (SG4) > SG4 - Final Documents |
| Title | Description | Posted Date | Size | Comments To |
|---|---|---|---|---|
| Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements | 24 October 2008 | 36 pages | ||
| 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 |
Guidelines for Regulatory Auditing of Quality Management |
31 August 2006 | 33 pages | |
| 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 |
*Reposted dates indicate when the document was reposted with a standard format cover sheet.
Updated 16 September 2009
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