Clinical evaluation requirements under the new European Union medical device regulation

被引：0
|
作者：
Hernandez, Gloria Hernandez [1 ]
机构：
[1] Agencia Espanola Medicamentos & Prod Sanitarios AE, Ctr Nacl Certificac Prod Sanitarios, Madrid, Spain
来源：
REC-INTERVENTIONAL CARDIOLOGY | 2024年 / 6卷 / 04期
关键词：
D O I：
10.24875/RECIC.M24000451
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
引用
收藏
页数：110
相关论文
共 50 条
  • [21] Risk-proportionate approach to paediatric clinical trials: The legal requirements, challenges, and the way forward under the European Union Clinical Trials Regulation
    Wan, Mandy
    Alessandrini, Elisa
    Brogan, Paul
    Eleftheriou, Despina
    Warris, Adilia
    Bruggemann, Roger
    Turner, Mark
    CLINICAL TRIALS, 2022, 19 (05) : 573 - 578
  • [22] Medical device regulation in the European Union, Japan and the United States. Commonalities, differences and challenges
    Altenstetter, Christa
    INNOVATION-THE EUROPEAN JOURNAL OF SOCIAL SCIENCE RESEARCH, 2012, 25 (04) : 362 - 388
  • [23] How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review
    Kramer, Daniel B.
    Xu, Shuai
    Kesselheim, Aaron S.
    PLOS MEDICINE, 2012, 9 (07)
  • [24] The impact of the European Union's Medical Device Regulation on orthopaedic implants, technology, and future innovation
    Staats, K.
    Kayani, B.
    Haddad, F. S.
    BONE & JOINT JOURNAL, 2024, 106B (04): : 303 - 306
  • [25] The new regulation of non-medical neurotechnologies in the European Union: overview and reflection
    Bublitz, Christoph
    Ligthart, Sjors
    JOURNAL OF LAW AND THE BIOSCIENCES, 2024, 11 (02):
  • [26] Device regulation in the European Union: response from MHRA
    Woods, Kent
    LANCET, 2012, 379 (9815): : 515 - 515
  • [27] An evaluation of the educational requirements to practise radiography in the European Union
    Couto, J. G.
    McFadden, S.
    Bezzina, P.
    McClure, P.
    Hughes, C.
    RADIOGRAPHY, 2018, 24 (01) : 64 - 71
  • [28] Requirements for Evaluation on Drug-medical Device
    DENG Jie1
    Chinese Journal of Biomedical Engineering, 2009, 18 (04) : 178 - 184
  • [29] Gastrointestinal endoscopy devices and the European Union Medical Device Regulation: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement
    Bretthauer, Michael
    Mori, Yuichi
    Zessner-Spitzenberg, Jasmin
    Kaminski, Michal F. F.
    Siersema, Peter D. D.
    Ponchon, Thierry
    Messmann, Helmut
    Gralnek, Ian M. M.
    Bisschops, Raf
    Hassan, Cesare
    ENDOSCOPY, 2023, 55 (06) : 578 - 581
  • [30] Regulation of Medical Devices in the United States and European Union
    Kramer, Daniel B.
    Xu, Shuai
    Kesselheim, Aaron S.
    NEW ENGLAND JOURNAL OF MEDICINE, 2012, 366 (09): : 848 - 855
12345