Postmarket surveillance for medical devices: America's new strategy

被引：24
|
作者：
Normand, Sharon-Lise T. [1 ]
Hatfield, Laura [1 ]
Drozda, Joseph [2 ]
Resnic, Frederic S. [3 ]
机构：
[1] Harvard Univ, Sch Med, Dept Hlth Care Policy, Boston, MA 02115 USA
[2] Sisters Mercy Hlth Syst, Chesterfield, MO USA
[3] Lahey Clin Med Ctr, Dept Cardiovasc Med, Burlington, MA 01803 USA
来源：
BRITISH MEDICAL JOURNAL | 2012年 / 345卷
关键词：
D O I：
10.1136/bmj.e6848
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
引用
收藏
页数：3
相关论文
共 50 条
  • [1] EU postmarket surveillance plans for medical devices
    Pane, Josep
    Francisca, Reynold D. C.
    Verhamme, Katia M. C.
    Orozco, Marcia
    Viroux, Hilde
    Rebollo, Irene
    Sturkenboom, Miriam C. J. M.
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2019, 28 (09) : 1155 - 1165
  • [2] Current development in medical devices postmarket surveillance in Taiwan
    Lan, Cheng-Wen
    Yeh, Ming-Kung
    Wu, Shiow-Ing
    Tu, Pei-Weng
    JOURNAL OF FOOD AND DRUG ANALYSIS, 2015, 23 (01) : 164 - 165
  • [3] Blockchain technology applications to postmarket surveillance of medical devices
    Pane, Josep
    Verhamme, Katia M. C.
    Shrum, Lacey
    Rebollo, Irene
    Sturkenboom, Miriam C. J. M.
    EXPERT REVIEW OF MEDICAL DEVICES, 2020, 17 (10) : 1123 - 1132
  • [4] THE SAFE MEDICAL DEVICES ACT OF 1990 - POSTMARKET SURVEILLANCE, MDR, AND OTHER POSTMARKET ISSUES
    BASILE, EM
    FOOD AND DRUG LAW JOURNAL, 1991, 46 (02): : 165 - 175
  • [5] Postmarket surveillance of medical devices: current capabilities and future opportunities
    Kathleen Blake
    Journal of Interventional Cardiac Electrophysiology, 2013, 36 : 119 - 127
  • [6] Postmarket surveillance of medical devices: current capabilities and future opportunities
    Blake, Kathleen
    JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY, 2013, 36 (02) : 119 - 127
  • [7] Postmarket Surveillance of Neuroendovascular Devices
    Luff, Marie K.
    Sedrakyan, Art
    Ansari, Sameer A.
    Siddiqui, Adnan H.
    Liebeskind, David S.
    STROKE-VASCULAR AND INTERVENTIONAL NEUROLOGY, 2024, 4 (02):
  • [8] Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
    Kramer, Daniel B.
    Baker, Matthew
    Ransford, Benjamin
    Molina-Markham, Andres
    Stewart, Quinn
    Fu, Kevin
    Reynolds, Matthew R.
    PLOS ONE, 2012, 7 (07):
  • [9] Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance
    Zippel, Claus
    Bohnet-Joschko, Sabine
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2017, 51 (02) : 237 - 245
  • [10] Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance
    Claus Zippel
    Sabine Bohnet-Joschko
    Therapeutic Innovation & Regulatory Science, 2017, 51 : 237 - 245
12345