On the new regulation of medical devices in Europe

被引:25
|
作者
Migliore, Antonio [1 ]
机构
[1] Agenas, Agenzia Nazl & Serv Sanitari Reg, Innovat & Dev Dept, Rome, Italy
关键词
Medical devices; regulation; CE mark; high-risk; class III; Europe;
D O I
10.1080/17434440.2017.1407648
中图分类号
R318 [生物医学工程];
学科分类号
0831 ;
摘要
引用
收藏
页码:921 / 923
页数:3
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