整形与美容医疗器械临床试验风险管理
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杨海洪(1970.2-),男,山东济南人,本科,工程师,主要从事医疗器械相关研究

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R197.39

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Risk Management of Clinical Trials of Plastic and Cosmetic Medical Devices
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    摘要:

    整形与美容行业发展迅速,医疗器械产业规模也在逐渐扩大。但我国现阶段医疗器械临床研究 管理方案尚需进一步完善,部分科研机构管理观念较弱,导致部分伪劣商品流入市场。本文主要总结整形 与美容医疗器械临床试验发展现状及存在的问题,并提出医疗设备临床研究和临床试验管理策略,以期 提升医疗器械临床研究人员对风险的认知,健全与完善整形与美容医疗器械临床试验风险的管理。

    Abstract:

    The plastic and cosmetic industry has developed rapidly, and the scale of medical device industry is also gradually expanding. However, China's current medical device clinical research management program still needs to be further improved, some research institutions management concept is weak, resulting in some fake commodities into the market. This paper mainly summarizes the current situation and existing problems of clinical trials of plastic and cosmetic medical devices, and puts forward the management strategies of clinical research and clinical trials of medical devices, in order to improve the risk awareness of medical device clinical researchers, and improve and perfect the risk management of plastic and cosmetic medical device clinical trials.

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杨海洪.整形与美容医疗器械临床试验风险管理[J].医学美学美容,2022,31(3):106-108.

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  • 在线发布日期: 2022-08-29
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