Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance

被引:0
|
作者
Claus Zippel
Sabine Bohnet-Joschko
机构
[1] Witten/Herdecke University,Walcker Endowed Professor of Management and Innovation in Health Care, Faculty of Management and Economics
关键词
innovation management; knowledge transfer; postmarketing; product surveillance; quality and risk management; regulation;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
页码:237 / 245
页数:8
相关论文
共 50 条
  • [21] Harnessing the Power of Collaboration for Postmarket Surveillance of Hernia Mesh Devices
    Prabhu, Ajita S.
    Poulose, Benjamin K.
    Rosen, Michael J.
    ANNALS OF SURGERY, 2020, 271 (02) : 221 - 222
  • [22] FDA perspectives on postmarket surveillance of peripheral and aortic vascular devices
    Malone, Misti
    Johnson, Carmen Gacchina
    CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 2024, 104 (01) : 170 - 171
  • [23] Postmarket Surveillance for Effective Regulation of Digital Mental Health Treatments
    Mohr, David C.
    Meyerhoff, Jonah
    Schueller, Stephen M.
    PSYCHIATRIC SERVICES, 2023, 74 (11) : 1114 - 1115
  • [24] Oversight Overhaul: Eliminating the Premarket Review of Medical Devices and Implementing a Provider-Centered Postmarket Surveillance Strategy
    Scott, Bonnie
    FOOD AND DRUG LAW JOURNAL, 2011, 66 (03) : 377 - 404
  • [25] Improving FDA postmarket adverse event reporting for medical devices
    Wunnava, Susmitha
    Miller, Timothy A.
    Bourgeois, Florence T.
    BMJ EVIDENCE-BASED MEDICINE, 2023, 28 (02) : 83 - 84
  • [26] Active Surveillance of Postmarket Medical Product Safety in the Federal Partners' Collaboration
    Robb, Melissa A.
    Racoosin, Judith A.
    Worrall, Chris
    Chapman, Summer
    Coster, Trinka
    Cunningham, Francesca E.
    MEDICAL CARE, 2012, 50 (11) : 948 - 953
  • [27] The US Food and Drug Administration's Approach for Safe Innovation of Medical Devices in Dermatology
    Chang, Cynthia J.
    Ashar, Binita S.
    Marquart, Laura N.
    JAMA DERMATOLOGY, 2018, 154 (03) : 261 - 263
  • [28] Postmarketing Surveillance of Medical Devices
    Villegas, Dorian
    Ye, Wendy
    Ayela-Wangue, Osas
    Schneiweiss, Fred
    Babuschak, Jeff
    Yonren, Samuel
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2011, 20 : S234 - S234
  • [29] Distribution shift detection for the postmarket surveillance of medical AI algorithms: a retrospective simulation study
    Koch, Lisa M.
    Baumgartner, Christian F.
    Berens, Philipp
    NPJ DIGITAL MEDICINE, 2024, 7 (01)
  • [30] A Comprehensive Analysis of Postmarket Surveillance Study Orders: Device Characteristics, Study Statuses, Outcomes, and Potential Contributions
    Iwaishi, Chie
    Iwasaki, Kiyotaka
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020, 54 (04) : 953 - 963