Discussion on quality control in clinical trials of interventional valvular medical devices

Jin Sun; Qi Zhang; Di Zhang; Qian Ren; Lun Zhou; Yanyan Cui; Jing Niu; Xichun Tian; Jingwen Wang; Zhongying MA

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Discussion on quality control in clinical trials of interventional valvular medical devices

VernacularTitle:介入瓣膜类医疗器械临床试验质量控制要点探讨
Author: Jin SUN ^{1
,

2} ; Qi ZHANG ^{3
,

4} ; Di ZHANG ^{1
,

2} ; Qian REN ^{1
,

2} ; Lun ZHOU ^{1
,

2} ; Yanyan CUI ^{1
,

2} ; Jing NIU ^{1
,

2} ; Xichun TIAN ^{1
,

2} ; Jingwen WANG ^{1
,

2} ; Zhongying MA ^{1
,

2}
Author Information

1. Department of Pharmacy, The First Affiliated Hospital of Air Force Medical University, Xi&rsquo
2. an, 710032, P. R. China
3. Shanxi Center for Drug and Vaccine Inspection, Xi&rsquo
4. an, 710065, P. R. China
Publication Type:Journal Article
Keywords: Heart valve; intervention; medical device; clinical trial; quality control
From: Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(09):1240-1245
CountryChina
Language:Chinese
Abstract: With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.