The Global Harmonization Task Force (GHTF) recently had a meeting and with that came a slew of final documents that were issued on 2 Nov 2012.
- Essential Principles of Safety & Performance of Medical Devices GHTF/SG1/N68:2012 supersedes GHTF/SG1/N41:2005
- Principles of Conformity Assessment for Medical Devices GHTF/SG1/N78:2012 supersedes GHTF/SG1/N40:2006
- Principles of Medical Devices Classification GHTF/SG1/N77:2012 supersedes GHTF/SG1/N15:2006
- Quality Management System – Medical Devices – Nonconformity Grading System for Regulatory Purposes & Information Exchange GHTF/SG3/N19:2012
- Clinical Evidence for IVD Medical Devices – Clinical Performance Studies for In Vitro Diagnostic Medical Devices GHTF/SG5/N8:2012
- Clinical Evidence for IVD Medical Devices – Scientific Validity Determination & Performance GHTF/SG5/N7:2012
- Clinical Evidence for IVD Medical Devices – Key Definitions & Concepts GHTF/SG5/N6:2012
GHTF Just Released New & Updated Documents