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Global Harmonization Task Force
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661	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 Information technology audit ISO Global Harmonization Task Force Information technology audit process Financial audit Auditing Accountancy Business
662	Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers Part 5: Audits of manufacturer control of suppliers GHTF/SG4/N84 R13:[removed]Study Group 4 - Final Document Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:11 Medical equipment Medicine Systems engineering Auditing Quality Global Harmonization Task Force ISO Audit Medical device Business Technology Quality management
663	PUBLIC CONSULTATION ON THE REVISION OF D IRECTIVE ON IN VITRO DIAGNOST IC MEDICAL DEVICES[removed]EC Response from the European Diagnostics Manufacturers Association Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-03 12:19:43 Medical device Global Harmonization Task Force In vitro diagnostics CE mark Medical Devices Directive Notified Body ISO 13485 IVD Technology Medical technology Medical equipment
664	HOPE ANSWERS TO THE PUBLIC CONSULTATION REVISION OF DIRECTIVE[removed]EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 27 OCTOBER 1998 ON IN VITRO DIAGNOSTIC MEDICAL DEVICES Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-03 12:19:24 Medical device Global Harmonization Task Force CE mark Medical diagnosis Diagnostic test Genetic testing Validity Medicine Medical equipment Medical technology
665	ASSOCIATION FOR CLINICAL CYTOGENETICS REDSPONSE TO REVISION OF DIRECTIVE[removed]EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 27 OCTOBER 1998 ON IN VITRO DIAGNOSTIC MEDICAL DEVICES PUBLIC CONSULTATION Introduction Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-03 12:24:30 Medical device Medical genetics Genetic testing CE mark Global Harmonization Task Force Medical Devices Directive Medical diagnosis In vitro diagnostics Medicine Medical equipment Medical technology
666	British In Vitro Diagnostics Association.doc Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-03 12:20:26 Medical equipment Medical device Global Harmonization Task Force In vitro diagnostics CE mark Genetic testing Medical diagnosis Validity Medicine Medical technology Technology
667	Microsoft Word - mimeattach2760.bin Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-03 12:04:51 Medical device CE mark Global Harmonization Task Force Medical diagnosis Genetic testing Diagnostic test Validity Prenatal diagnosis Medicine Medical equipment Medical technology
668	[removed]Tooley St London SE1 2TU Tel[removed]Fax[removed]Email [removed] Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-03 12:19:06 Medical device CE mark Genetic testing Medical diagnosis Global Harmonization Task Force Medicine Medical equipment Medical technology
669	IMDRF/WG/N7FINAL:2013 Final Document Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2013-12-17 19:37:44 Automatic identification and data capture Food and Drug Administration Unique Device Identification Medical technology Global Harmonization Task Force Medical device GMDN Packaging and labeling Barcode Technology Medicine Medical equipment
670	European Centre for Disease Prevention and Control (ECDC) comments to European Commission public consultation on Revision of Directive[removed]EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-03 12:19:45 Medical technology Medical device CE mark Global Harmonization Task Force Medical diagnosis Physical therapy Genetic testing Medicine Medical equipment Medical tests

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