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Harmonization
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#	Item
811	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
812	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
813	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
814	SUMMARY OF THE 10th GHTF STEERING COMMITTEE The 10th GHTF Steering Committee (SC) meeting was held in Lübeck, Germany from June 26 to 27, [removed]Welcome and apologies The Chair welcomed everyone to Lübeck. Mrs. Georg Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:19 Technology Global Harmonization Task Force Clinical research Pharmaceutical industry Medical technology Medical device GMDN Clinical trial Adverse event Medicine Medical equipment Health
815	Study Group 4: Auditing. Guidelines for regulatory auditing of quality systems of medical device manufacturers: part 2: language requirements: [removed]Proposed document Study Group 4: Auditing. Guidelines for regu Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:08 Auditing Global Harmonization Task Force Health Pharmaceutical industry Pharmaceuticals policy Medical device Documentation Title 21 CFR Part 11 ISO Medical equipment Medicine Technology
816	Highlights of the SG2 meeting held Oct 18-20, 1999 in Minneapolis, Minnesota Several updates were given on various projects, including the status of: the document review process: now under the direction of Beth Pieterso Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:42 Health Global Harmonization Task Force Medical device Food and Drug Administration Report Medicine Medical equipment Technology
817	LIST OF TRAINERS FOR STUDY GROUP 2 (SG2)- May[removed]This list contains the names of the people who meet the criteria to speak or train on the Global Harmonization Task Force’s (GHTF) SG2 documents including the Nationa Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-26 18:05:07 Global Harmonization Task Force Medical equipment Ishii
818	SG2 meeting highlights from Ottawa, Canada, Dates: 18-20 October 2000 Study Group 2 (SG2) along with the other Study Groups of the Global Harmonization Task Force (GHTF), met in Ottawa in conjunction with activities of 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 Report Food and Drug Administration Medicine Medical equipment Technology
819	GLOBAL HARMONISATION TASK FORCE STUDY GROUP 5 – CLINICAL EVIDENCE Minutes of Meeting Wednesday 14 September and Thursday 15 September 2005 Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:53:12 Medical device SG1 Evaluation International Organization for Standardization Medical equipment Technology Global Harmonization Task Force
820	Clinical Evidence – Key Definitions and Concepts Study Group 5 Proposed Document SG5(PD)N1R7 SG5(PD)N1R7 Add to Reading List Source URL: www.imdrf.org Language: English - Date: 2012-11-13 17:52:27 Health Medical equipment Technology Validity Pharmacology Global Harmonization Task Force Clinical trial Medical device ISO 14155 Pharmaceutical industry Medicine Clinical research

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