中国药物警戒 ›› 2010, Vol. 7 ›› Issue (9): 547-550.

• 管理及工作研究 • 上一篇    下一篇

对医疗器械临床试验实施全过程质量管理的探讨

陆飞12,程云章1   

  1. 1.上海理工大学医疗器械与食品学院,上海 200093；
    2.南京市食品药品监督管理局,江苏南京 210007
  • 收稿日期:2010-05-20 修回日期:2016-03-09 出版日期:2010-09-08 发布日期:2016-03-09
  • 通讯作者: 程云章,男,研究生导师,医疗器械安全工程研究。E-mail: cyz2008@usst.edu.cn
  • 作者简介:陆飞,男,在读硕士研究生,医疗器械质量安全研究。

The Investigation for Perform the Quality Management of Medical Device During the Whole Process of Clinical Trial

LU Fei1,2 ,CHENG Yun-Zhang1   

  1. 1.School of Medical Instrument and Food Engineering,University of Shanghai for Science and Technology,Shanghai 200093,China;
    2.Nanjing Food and Drug Administration, Jiangsu Nanjing 210007, China
  • Received:2010-05-20 Revised:2016-03-09 Online:2010-09-08 Published:2016-03-09

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摘要： 医疗器械的发展需要新的科学技术在医疗临床的应用,临床试验报告是临床数据的内容之一,其真实性、准确性和科学性关系到产品安全性和有效性的评价,更关系到人体生命安全,因此对临床试验全过程加以科学监管尤为必要。

关键词: 临床试验, 医疗器械, 全过程质量管理

Abstract: The developing of medical device requires the application of advanced scientific technology. Clinical trial is one of the most important Methods to obtain the basic clinical evaluation data. The truthful, accuracy and scientific of the data have a serious relationship with the safety and efficiency of the products and the life safety of human. Therefore, it is very important to scientific monitor and control the whole process of clinical trial.

Key words: clinical trial, medical device, process quality management

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