Medical device Variable Study evidence after the Approval

被引:0
|
作者
Rukavina, Marion
机构
来源
PNEUMOLOGIE | 2016年 / 70卷 / 02期
关键词
D O I
暂无
中图分类号
R56 [呼吸系及胸部疾病];
学科分类号
摘要
引用
收藏
页码:80 / 80
页数:1
相关论文
共 50 条
  • [1] High-risk Medical Devices Variable evidence after approval Comment
    Zens, Yvonne
    PNEUMOLOGIE, 2016, 70 (02): : 80 - 80
  • [2] THE STANDARD OF EVIDENCE REQUIRED FOR PREMARKET APPROVAL UNDER THE MEDICAL DEVICE AMENDMENTS OF 1976
    HUTT, PB
    MERRILL, RA
    KIRSCHENBAUM, AM
    FOOD AND DRUG LAW JOURNAL, 1992, 47 (06): : 605 - 628
  • [3] The Long and Winding Road After FDA Approval A Medical Device Industry Perspective
    Stein, Kenneth M.
    CIRCULATION, 2017, 135 (20) : 1877 - 1878
  • [4] Medical Device Recalls and the FDA Approval Process
    Zuckerman, Diana M.
    Brown, Paul
    Nissen, Steven E.
    ARCHIVES OF INTERNAL MEDICINE, 2011, 171 (11) : 1006 - 1011
  • [5] Speeding up medical-device approval
    Kiernan, V
    LASER FOCUS WORLD, 1998, 34 (01): : 67 - 68
  • [6] Overview of the US FDA Medical Device Approval Process
    Sastry, Ashwani
    CURRENT CARDIOLOGY REPORTS, 2014, 16 (06)
  • [7] Overview of the US FDA Medical Device Approval Process
    Ashwani Sastry
    Current Cardiology Reports, 2014, 16
  • [8] Medical device development - From prototype to regulatory approval
    Kaplan, AV
    Baim, DS
    Smith, JJ
    Feigal, DA
    Simons, M
    Jefferys, D
    Fogarty, TJ
    Kuntz, RE
    Leon, MB
    CIRCULATION, 2004, 109 (25) : 3068 - 3072
  • [9] A case study regarding clinical performance evaluation method of medical device software for approval
    Shimizu, Koji
    Aoyama, Gakuto
    Nishio, Mizuho
    Yakami, Masahiro
    Kubo, Takeshi
    Emoto, Yutaka
    Ito, Tatsuya
    Kuroda, Tomohiro
    Isoda, Hiroyoshi
    MEDICAL IMAGING 2019: IMAGE PERCEPTION, OBSERVER PERFORMANCE, AND TECHNOLOGY ASSESSMENT, 2019, 10952
  • [10] MEDICAL DEVICE APPROVAL SYSTEM: IS PMA MORE EFFECTIVE THAN 510(K)? STUDY OF RECALLED MEDICAL DEVICES
    McEwen, P.
    Molnar, J.
    Basu, S.
    Somberg, J. C.
    JOURNAL OF INVESTIGATIVE MEDICINE, 2012, 60 (04) : 725 - 726