The new European regulatory framework for medical devices: opportunities for engagement by electrophysiologists

被引：2
|
作者：
Szymanski, Piotr [1 ,2 ]
Leggeri, Ilaria [3 ]
Kautzner, Josef [2 ,4 ]
Fraser, Alan G. [2 ,5 ,6 ]
机构：
[1] Inst Cardiol, Alpejska 42, PL-04628 Warsaw, Poland
[2] ESC EU Regulatory Affairs Comm Med Devices, European Heart House,2035 Route Colles, F-06903 Sophia Antipolis, France
[3] European Soc Cardiol, Advocacy & Representat Div, European Heart House,2035 Route Colles, F-06903 Sophia Antipolis, France
[4] Charles Univ Prague, Med Sch I, Inst Clin & Expt Med, Videnska 1958-9, CZ-14021 Prague, Czech Republic
[5] Cardiff Univ, Cardiff, S Glam, Wales
[6] Univ Wales Hosp, Wales Heart Res Inst, Heath Pk, Cardiff CF14 4XN, S Glam, Wales
来源：
EUROPACE | 2018年 / 20卷 / 06期
关键词：
CORONARY STENTS; SOCIETY;
D O I：
10.1093/europace/eux344
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
[No abstract available]
引用
收藏
页码：902 / 905
页数：4
相关论文
共 50 条
  • [31] A Concept for a Japanese Regulatory Framework for Emerging Medical Devices with Frequently Modified Behavior
    Ota, Nagomi
    Tachibana, Keisuke
    Kusakabe, Tetsuya
    Sanada, Shoji
    Kondoh, Masuo
    [J]. CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2020, 13 (05): : 877 - 879
  • [32] Substantial Amendment of the EU Regulatory Framework on Medical Devices and International Trade Implications
    Carreno, Ignacio
    [J]. EUROPEAN JOURNAL OF RISK REGULATION, 2013, 4 (01) : 97 - 100
  • [33] Regulatory Reticence and Medical Devices
    Fox, Daniel M.
    Zuckerman, Diana M.
    [J]. MILBANK QUARTERLY, 2014, 92 (01): : 151 - 159
  • [34] Regulatory Deficits in Medical Devices
    Freckmann, G.
    Pleus, S.
    Heinemann, L.
    Koschinsky, T.
    [J]. DIABETOLOGE, 2016, 12 (08): : 558 - 565
  • [35] How the new European regulation on medical devices will affect innovation
    Ben-Menahem, Shiko M.
    Nistor-Gallo, Raymond
    Macia, Gloria
    von Krogh, Georg
    Goldhahn, Joerg
    [J]. NATURE BIOMEDICAL ENGINEERING, 2020, 4 (06) : 585 - 590
  • [36] How the new European regulation on medical devices will affect innovation
    Shiko M. Ben-Menahem
    Raymond Nistor-Gallo
    Gloria Macia
    Georg von Krogh
    Jörg Goldhahn
    [J]. Nature Biomedical Engineering, 2020, 4 : 585 - 590
  • [37] Advanced therapy: From European regulatory framework to national regulatory framework
    Lucas-Samuel, S.
    [J]. TRANSFUSION CLINIQUE ET BIOLOGIQUE, 2013, 20 (02) : 221 - 224
  • [38] The Regulatory Environment for the Safety of the Internet of Medical Devices Users in the European Union and the United States
    Biczysko-Pudelko, Katarzyna
    [J]. EUROPEAN JOURNAL OF RISK REGULATION, 2024,
  • [39] Opportunities for Medical Student Engagement With Family Medicine
    Heidelbaugh, Joel
    Cooke, James
    Wimsatt, Leslie
    [J]. FAMILY MEDICINE, 2013, 45 (07) : 484 - 491
  • [40] Regulatory measures for implementing new medical devices.: Recalling Boneloc®
    Riehmann, M
    [J]. DANISH MEDICAL BULLETIN, 2005, 52 (01) : 11 - 17
12345