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

SG4 - Archived Documents

Title
Description
Posted Date
SG4(PD) / N30R16
[PDF][Word]
Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy 17 November 2005
SG4(PD)N33R13:2006
[Word] [PDF]
Guidelines for Regulatory Auditing of Quality
Management Systems of Medical Device Manufacturers –
Part 3: Regulatory Audit Reports
18 December 2006

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Updated 20 November 2007