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

Chinese Journal of Pharmacovigilance ›› 2010, Vol. 7 ›› Issue (9): 547-550.

Previous Articles Next Articles

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

LU Fei^1,2 ,CHENG Yun-Zhang¹

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

Abstract

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

CLC Number:

R955
R197.39

LU Fei ,CHENG Yun-Zhang . The Investigation for Perform the Quality Management of Medical Device During the Whole Process of Clinical Trial [J]. Chinese Journal of Pharmacovigilance, 2010, 7(9): 547-550.

[1]	LIU Min, CHEN Yan, LIU Wendong, WANG Haixue. Updates and reflections on expedited reporting of safety information during drug clinical trials [J]. Chinese Journal of Pharmacovigilance, 2024, 21(1): 98-101.
[2]	MA Ruize, CHEN Zhihai. The latest progress of small molecule anti-SARS-CoV-2 drugs [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 961-966.
[3]	SHEN Yanjie, WU Yiqing. Management of adverse events during clinical trials [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 982-986.
[4]	LIU Wendong, CUI Huanhuan, WANG Xiaohan, SU Xian, WANG Haixue. Status and thinking of Parmacovigilance regulatory system during clinical trials of the pediatric drug in China [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1002-1006.
[5]	ZHANG Qi, CHEN Min, ZHANG Shiqing. Conditional approval of medical devices in the United States and enlightenment [J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1007-1010.
[6]	ZHAO Yan, LIU Wenbo, ZHAO Yifei, LI Dong, ZHENG Lijia, SONG Yana, ZHAO Yujuan, DONG Fang. Applicability of patient registry research to regulation of medical devices [J]. Chinese Journal of Pharmacovigilance, 2023, 20(4): 423-427.
[7]	ZHAO Yan, LI Dong, CHENG Yinjie, JIANG Bin, ZHAO Yifei, DONG Fang, YUAN Jing. Advances in studies on post-market safety data sources and signal detection for medical devices [J]. Chinese Journal of Pharmacovigilance, 2023, 20(2): 236-240.
[8]	ZHAO Yan, LI Yao, SONG Ya’na, ZHENG Lijia, LI Dong, ZHAO Yifei, BIAN Rongrong, DONG Fang. Post-marketing active monitoring of medical devices under vigilance [J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1385-1390.
[9]	MU Sicong, WANG Zhuo, LU Junyang, JI Liwei, LIU Xin. Effects of pioglitazone on plasma adiponectin in patients with type 2 diabetes mellitus: a Meta-analysis [J]. Chinese Journal of Pharmacovigilance, 2022, 19(9): 1015-1018.
[10]	SHEN Chuanyong, SONG Yana, ZHAO Yan, ZHENG Lijia, ZHAO Yifei, LI Dong. Thoughts on constructing vigilance system of Chinese medical device in the new era [J]. Chinese Journal of Pharmacovigilance, 2022, 19(7): 697-701.
[11]	TENG Yingying, LI Chaiquan, XU Yang, TANG Xun, GAO Pei. Progress in the application of real-world data in post-market surveillance of medical devices [J]. Chinese Journal of Pharmacovigilance, 2022, 19(3): 233-238.
[12]	LIU Min, PEI Xiaojing, WANG Haixue. Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China [J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 176-179.
[13]	CUI Huanhuan, PEI Xiaojing, LI Yanrong, LIU Wendong, WANG Haixue, LAN Gongtao, WANG Tao. The practice and consideration of pharmacovigilance during clinical trials in China [J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1050-1054.
[14]	ZHAO Yifei, ZHAO Yan, DONG Fang, ZHENG Lijia, LI Dong, SONG Yana. Introduction and inspiration of international medical device regulators forum patient registry guidelines [J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1091-1096.
[15]	ZHAO Zhe, ZHANG Qing, GE Ziruo, ZHANG Wei, CHEN Zhihai. Giant progress in small molecule antiviral drugs for SARS-CoV-2 [J]. Chinese Journal of Pharmacovigilance, 2022, 19(1): 1-6.

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

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 15

Recommended Articles

Metrics