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Harmonization
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801	Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers: Supplement No. 6: Guidance for Conducting Observed Audits of Conformity Assessment Bodies. GHTF/SG4/N26R1:2001 Study Group 4 – Fina Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:08 Business Information technology audit process Environmental audits Auditing Global Harmonization Task Force Audit
802	Summary of SG2 Meeting SG2 met in Stuttgart, Germany from[removed]April[removed]Seventeen members from industry and regulatory agencies met under the leadership of Chair Larry Kessler. Dr. Kessler identified the following m Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:41 Global Harmonization Task Force Health Medical device Adverse event Food and Drug Administration Guidance document Medicine Medical equipment Technology
803	GHTF SG3 - Quality Systems Minutes of Meeting June[removed]Welcome and Introductions Kim Trautman welcomed members to Washington and the meeting. The first day of the meeting was open to observers and Kim described the n Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:55 Medical technology Quality Global Harmonization Task Force ISO Medical device Validation Quality management system Medicine Technology Medical equipment
804	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
805	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
806	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
807	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
808	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
809	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
810	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

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