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| “以患者为中心”在医疗器械研发中的价值和应用 | |
| 引用本文： | 尹立强,赵杨升,马伟. “以患者为中心”在医疗器械研发中的价值和应用[J]. 中国医疗器械信息, 2021, 0(1) |
| 作者姓名： | 尹立强 赵杨升 马伟 |
| 作者单位： | 山东大学公共卫生学院;烟台正海生物科技股份有限公司 |
| 基金项目： | 国家重点研发计划,生殖健康及重大出生缺陷防控研究重点专项(项目编号:2016YFC1000800)。 |
| 摘 要： | 从“以患者为中心”的角度,结合国内医疗器械产业的基本现状、研发存在的问题等背景,介绍了“以患者为中心”的基本理念,从行业实践者的角度,对在研发活动中引入“以患者为中心”的重要性及如何践行进行了陈述。为医疗器械领域尽快引入“以患者为中心”的理念和实践性的纲领文件提供参考。 |
| 关 键 词： | 以患者为中心 医疗器械研发 医疗器械监管 |
The Value and Application of Patient-Focused in Medical Device Research and Development |
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| YIN Li-qiang,ZHAO Yang-sheng,MA Wei. The Value and Application of Patient-Focused in Medical Device Research and Development[J]. China Medical Devices Information, 2021, 0(1) | |
| Authors: | YIN Li-qiang ZHAO Yang-sheng MA Wei |
| Affiliation: | (School of Public Health,Shandong Universit,Shandong Jinan 250012;Yantai Zhenghai Bio-Tech Co.,Ltd.,Shandong Yantai 264006) |
| Abstract: | This article introduces the basic concept of"patient-focused"combined with the basic status of the domestic medical device industry and the existing problems in research and development.From the perspective of industry practitioners,the importance of introducing"patient-focused"in R&D activities and how to implement it were stated.It provides a reference for the introduction of the"patient-focused"concept and practical program documents in the field of medical devices as soon as possible. |
| Keywords: | patient-focused medical device research and development medical device supervision |
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