An International Vascular Registry Infrastructure for Medical Device Evaluation and Surveillance.
An International Vascular Registry Infrastructure for Medical Device Evaluation and Surveillance.
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用于医疗器械评估和监测的国际血管登记基础设施。
DOI：
10.1016/j.ejvs.2017.01.002
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Björck,M
中科院分区：
文献类型：
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作者：
Sedrakyan,A;Cronenwett,JL;Venermo,M;Kraiss,L;Marinac-Dabic,D;Björck,M
医疗器械流行病学网络（MDEpiNet）是由美国食品和药物管理局（FDA）支持的一项创新努力，致力于发展医疗器械科学和监测基础设施。最近，MDEpiNet赞助了一个国家医疗器械注册工作组，该工作组为21世纪医疗器械评估制定了一份指导文件，强调了国家和国际注册的重要性、它们与其他相关数据的联系以及利益攸关方参与。国际骨科注册协会（ICOR）和国际心血管注册协会（ICCR）在过去4年启动了两项国际努力，研究骨科和心血管设备在这方面的应用。
The Medical Device Epidemiology Network (MDEpiNet) is an innovative effort supported by the US Food and Drug Administration (FDA) that is committed to the development of a medical device science and surveillance infrastructure. Recently MDEpiNet sponsored a national medical device registry task force which developed a guidance document for 21st century medical device evaluation that highlights the importance of national and international registries, their linkages with other relevant data, and stakeholder involvement. 1 Two international efforts, the International Consortium of Orthopedic Registries (ICOR) and the International Consortium of Cardiovascular Registries (ICCR) 2 were launched in the past 4 years to study orthopedic and cardiovascular devices in this regard.