https://eisnersafety.com Regulatory & Safety Experts for Global Medical Device Approvals Wed, 07 Nov 2012 08:36:05 +0000 en-US hourly 1 https://eisnersafety.com/wp-content/uploads/2025/08/favicon-45x45.png https://eisnersafety.com 32 32 https://eisnersafety.com/2012/11/07/ghtf-just-released-new-updated-documents/?utm_source=rss&utm_medium=rss&utm_campaign=ghtf-just-released-new-updated-documents Wed, 07 Nov 2012 08:36:05 +0000 http://www.eisnersafety.com/eisnersafetycom/?p=2830 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

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