1992 -

Working Towards Harmonization in Medical Device Regulation

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GHTF Documents

• Premarket Evaluation - Study Group 1
  • Proposed Documents
  • Final Documents
    
• Post-Market Surveillance/Vigilance - Study Group 2
  • Proposed Documents
  • Final Documents
    
• Quality Systems - Study Group 3
  • Proposed Documents
  • Final Documents
    
• Auditing - Study Group 4
  • Proposed Documents
  • Final Documents
    
• Clinical Safety/Performance - Study Group 5
  • Proposed Documents
  • Final Documents
    
• GHTF Ad Hoc Working Group (AHWG)
  • Proposed Documents
  • Final Documents
    
• GHTF Retrospective Assessment
  • Key Findings and Recommendations (PDF)
  • Statement From the Chair (PDF)

Updated 15 April 2011

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