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Global Harmonization Task Force
Results: 752

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171	Medical Devices: Post Market Surveillance: An XML schema for the electronic transfer of adverse event data between manufacturers, authorised representatives and National Competent Authorities (Based on GHTF SG2 N32v5.2) Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:53 Medicine Global Harmonization Task Force Medical device XML Schema XML Adverse event Medical equipment Computing Technology
172	GHTF - SG2 N106R3: Meeting Minutes, Washington, DC Page 1 of 6 GHTF SG2 Meeting Location: The Ronald Reagan Building and International Trade Center, Washington, DC, USA Date: 30 September – 2 October 2007 Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:43 Global Harmonization Task Force Medical informatics Health informatics Health Level 7 Medical device National Center for Atmospheric Research Food and Drug Administration Medicine Health Medical equipment
173	Summary 11th GHTF Steering Committee Meeting The 11th GHTF Steering Committee (SC) meeting was held on 29 and 30 November 2006 in Brussels. This meeting marked the end of the three year chairmanship of Europe. 1. Welcome Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:20 Health Medical technology Global Harmonization Task Force GMDN ISO/IEC JTC1 Medical device International Organization for Standardization International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ISO 13485 Medicine Medical equipment Technology
174	Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Study Group 1 Proposed Document SG1(PD)/N011R20 Summary Technical Documentation Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:24 Pharmaceutical industry Validity Science Medical technology Global Harmonization Task Force Clinical research Medical device Validation Verification and validation Technology Medicine Medical equipment
175	Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED) Study Group 1 Proposed Document SG1/N011R17 Summary Technical Documentation for Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:23 Pharmaceutical industry Validity Quality management Science Medical technology Global Harmonization Task Force Medical device Validation Documentation Technology Medicine Medical equipment
176	SUMMARY OF THE 7th GHTF STEERING COMMITTEE MEETING The seventh GHTF Steering Committee (SC) meeting was held in Paris on 28 and 29 June 2004, hosted by Afssaps, the French Health Products Agency. On that occasion, Mr. Ma Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:19 Health Medical technology Food and Drug Administration Global Harmonization Task Force GMDN Medical device Clinical research ISO 13485 Stargate SG-1 Medicine Technology Medical equipment
177	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers General Requirements Supplement No. 4 Compilation of Audit Documentation (Clause 5.7) SG4 N(99)24R3 Study Group 4 – Final Document G Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:09 Risk Global Harmonization Task Force Medical equipment Audit Business Corporate governance Single Audit Information technology audit process Clinical audit Auditing Accountancy Information technology audit
178	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 3: Regulatory Audit Report SG4 N33 R10 – Study Group 4 – Working Draft Guidelines for Regulatory Auditing of Qual Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:10 Risk Audit Global Harmonization Task Force Information technology audit ISO Information technology audit process Financial audit Auditing Accountancy Business
179	Highlights of the minutes of GHTF-SG2 compiled by Carl Wallroth during the meeting in Canberra, Australia on 18 and 19 February[removed]Chair: Larry Kessler, FDA, USA Acting Secretary: Carl Wallroth, Dräger, Germany, EU Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:41 Technology Health Economy of Europe Trade associations Global Harmonization Task Force Medical device European Medical Devices Industry Group Food and Drug Administration Eucomed Medicine Medical equipment Medical technology
180	GHTF - SG2 N129 Meeting Minutes Canberra , November2011 Page 1 of 9 GHTF SG2- 42nd Meeting minutes – Canberra, Australia Location: Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia, 136 Narrabunda Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:44 Global Harmonization Task Force Medical device Eucomed S4 Medical equipment Technology Medical technology

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