1992 -
Working Towards Harmonization
in Medical Device Regulation
in Medical Device Regulation
1992 - |
Working Towards Harmonization in Medical Device Regulation |
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| GHTF > Study Groups > Study Group 5 (SG5) > SG 5 Proposed Documents |
Title |
Description |
Posted Date |
Date Comments Due: |
Comments To |
|---|---|---|---|---|
| SG5(PD)/N8R3 | Clinical Performance Studies for In Vitro Diagnostic Medical Devices [Word] [PDF] [Comment Template] | 2 February 2012 | 2 June 2012 | Benny Ons |
| SG5(PD)/N6R3 | Clinical Evidence for IVD Medical Devices - Key Definitions and Concepts [Word] [PDF] [Comment Template] | 21 September 2011 | 21 March 2012 | Benny Ons |
| SG5(PD)/N7R4 | Clinical Evidence for IVD Medical Devices - Scientific Validity Determination and Performance Evaluation [Word] [PDF] [Comment Template] | 21 September 2011 | 21 March 2012 | Benny Ons |
| SG2&5(PD1)/N05R10 | Reportable Events During Pre-Market Clinical Investigations [Word] [PDF] | 10 June 2011 | 10 December 2011 | Greg LeBlanc |
Updated 2 February 2012
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