GHTF 质量管理系统-医疗设备 预防措施-QMS-Medical_Devices-Guidance_on_Corrective_Action_and_Preventive.pdf,1 SG3(PD)/N18R8 2 3 4 5 6 7 8 9 10 11 12 PROPOSED DOCUMENT 13 Global Harmonization Task Force 14 15 16 17 Title: Quality management system –Medical
Quality Management Systems – Process ValidationGuidanceüüAuthoring Group: SG3 3 Endorsed by: The Global Harmonization Task Force(GHTF)Date:Edition 2 - January ...
关键词: 医疗器械 标签 说明书 GHTF 指导原则GHTF Guidance on Label and Instruction for Use for Medical Devices LI Fei1,2 LIANG Wen1 FU Wei-wei3 YUAN Peng2 WEI Jing1 1 Liaoning Food and Drug Administration Technical Evaluation Center (Shenyang 110003) 2 China Food and Drug Administration (...
SG3(PD)/N18R81234567891011PROPOSEDDOCUMENT12GlobalHarmonizationTaskForce13141516Title:Qualitymanagementsystem–MedicalDevices–Guidanceoncorrectiveac-17tionandpreventiveactionandrelatedQMSprocesses1819AuthoringGroup:StudyGroup32021Date:22ndSeptember2009222324252627282930313233Guidanceoncorrectiveactionandpreventiveactionandrelated...
需要金币:*** 金币(10金币=人民币1元) GHTF-SG3-N99-10-2004 Process Validation Guidance外文电子书籍.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group:...
Title: Title: Title: Quality management system –Medical Devices – Guidance on corrective ac-Quality management system –Medical Devices – Guidance on corrective ac-Quality management system –Medical Devices – Guidance on corrective...
Evaluation,Guidance GHTF医疗器械临床评价是在 医疗器械安 全与性能基本要求 体系框架下建立的评价体系。 临床评价开始之前,需对照安全与性能基本要求 特征判定列表,鉴别哪些安全和/或性能需要临 床相关数据支持,依据其确定临床评价范围。通 过数据鉴别、数据评价、数据分析的过程最终形 ...
【中文版】GHTF Process Validation guidance工艺验证指南
GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance SG3 The Global Harmonization Task Force Edition 2 - January 2004 Authoring Group: Endorsed by: Date: Taisuke Hojo, GHTF Chair The document herein was produced by the Global ...
从陆地棉中克隆了磷脂酰乙醇胺结合蛋白GhTFL1a和GhTFL1c基因, 并对该基因进行表达分析、启动子预测和启动子活性研究。利用启动子分析软件PlantCARE预测得出,GhTFL1a启动子区域有脱落酸响应元件、干旱诱导的MYB结合位点和顶芽特异表达响应元件等;GhTFL1c启动子区域有乙烯响应元件、干旱诱导的MYB结合位点和水杨酸响应元件。因此...