文章摘要
张世庆,商惠,柳全明.医疗器械技术审评CAPA系统的构建与探讨[J].中国药事,2019,33(7):741-745
医疗器械技术审评CAPA系统的构建与探讨
Construction and Discussion of CAPAs for Medical Device Evaluation
投稿时间:2019-04-01  
DOI:10.16153/j.1002-7777.2019.07.004
中文关键词: 纠正和预防措施系统  质量管理体系  医疗器械  审评
英文关键词: corrective action and preventive action system  quality management system  medical device  evaluation
基金项目:基于增材制造的个性化植入假体质量标准规范及数字测评研究(编号2016YFB1101105)
作者单位
张世庆 国家药品监督管理局医疗器械技术审评中心, 北京 100089 
商惠 国家药品监督管理局医疗器械技术审评中心, 北京 100089 
柳全明 中国食品药品检定研究院, 北京 102600 
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中文摘要:
      目的:医疗器械的安全有效性评价事关公众健康,因此,建立确保评价质量的管理体系有重要意义。“纠正和预防措施系统”是质量管理体系的重要环节和有效工具,建立医疗器械技术审评“纠正和预防措施系统”,对于医疗器械评价质量的持续改进有举足轻重的作用。方法:本文就技术审评“纠正和预防措施系统”的构建进行了扼要介绍,并对其中涉及到的问题进行了初步探讨,以期为相关人员提供借鉴。结果与结论:“纠正和预防措施系统”的建立,对于规范医疗器械技术审评,降低审评风险,确保技术审评质量的不断提高发挥了重要作用。
英文摘要:
      Objective:Because the evaluation of safety and effectiveness of medical devices is related to public health, to establish a quality management system (QMS) and to ensure the quality of evaluation is of great significance. Corrective action and preventive action system (CAPAs) is an important link and an effective tool for QMS. The construction of CAPAs for medical devices evaluation plays a key role in the continuous improvement of the quality of the medical device evaluation. Methods:This paper briefly introduced the construction of CAPAs for medical device evaluation and and made a preliminary discussion on the problems involved in, in order to provide references for revelant personnel. Results and Conclusion:The construction of CAPAs plays an important role in regulating the action, reducing the risk and ensuring the continuous improvement of the quality of evaluation for medical devices.
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