(GHTF Logo)
         1992 - 
Global Harmonization Task Force
(Flags: European Union, United States of America, Canada, Australia, Japan)
Working Towards Harmonization
in Medical Device Regulation
 

SG4 - Final Documents

Title Description Posted Date Size Comments To

SG4/N28R4:2008
PDF Word

Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 1: General Requirements 24 October 2008 36 pages  

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 (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