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Global Harmonization Task Force
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161	DRAFT GUIDANCE DOCUMENT Preparation of the Summary Technical Documentation (STED)-based Class III and Class IV Premarket Medical Device Licence Applications Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:44:43 Medical equipment Validity Science Medical technology Clinical research Medical device Global Harmonization Task Force Verification and validation Validation Technology Medicine Pharmaceutical industry
162	Microsoft Word - SG1_princip14_IVD.Final SG1N41R9 2005 Doc.Mar05 updated.doc Add to Reading List Source URL: www.aami.org Language: English - Date: 2012-04-23 02:34:09 Medical technology Health Global Harmonization Task Force Pharmaceutical industry Medical device Validity Regulatory requirement Verification and validation Occupational safety and health Medicine Medical equipment Technology
163	Aug[removed], 2014 • Marriott Bethesda North Hotel and Conference Center Bethesda, MD An Interactive Workshop Presented by FDAnews and Ombu Enterprises Innovative Process Add to Reading List Source URL: www.fdanews.com Language: English - Date: 2014-07-03 16:16:38 Pharmaceutical industry Pharmaceutical sciences Validity Clinical research Quality Validation Global Harmonization Task Force Medical device Quality management system Medicine Medical equipment Technology
164	Embassy Briefing: Office of International Programs U.S. Food and Drug Administration Murray M. Lumpkin, M.D., M.Sc. Deputy Commissioner International Programs Add to Reading List Source URL: www.fda.gov Language: English Adulteration Chinese milk scandal Food safety Global Harmonization Task Force Medical equipment Melamine Food and Drug Administration Medicine Chemistry Health
165	Beyond Passive Surveillance: Unique Needs and Varied Approaches Thomas P. Gross, MD, MPH Director, Office of Surveillance and Biometrics Center for Devices and Radiological Health Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical sciences Pharmacology Clinical research French words and phrases National security Food and Drug Administration Global Harmonization Task Force Surveillance Adverse event Medicine Medical equipment Technology
166	New European Regulation for Medical Devices to Replace[removed]Eec and[removed]Eec Add to Reading List Source URL: www.nsf.org Language: English - Date: 2013-01-04 15:30:45 Medical technology Medical device Food and Drug Administration Global Harmonization Task Force Notified Body Directive Unique Device Identification Medicine Medical equipment Technology
167	A Vision for Regulatory Science and Decision Making Add to Reading List Source URL: www.fda.gov. Language: English Pharmaceutical sciences Pharmacology Pharmaceuticals policy Medical equipment Pharmaceutical industry Regulatory science Regulatory requirement Medical device Global Harmonization Task Force Medicine Food and Drug Administration Health
168	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
169	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
170	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

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