Requirements to bring a medical device to market

被引:0
|
作者
Buenz, Eric J. [1 ,2 ,3 ]
Wallace, Victoria M. [4 ]
Friedman, Suzanne Levy [4 ]
机构
[1] Mayo Clin, Rochester, MN 55905 USA
[2] Device Navigator, Motueka, New Zealand
[3] Nelson Marlborough Inst Technol, Nelson, New Zealand
[4] Hogan Lovells US LLP, Washington, DC USA
关键词
PREMARKET APPROVAL; FDA;
D O I
10.1016/j.tibtech.2024.07.016
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 ; 0836 ; 090102 ; 100705 ;
摘要
引用
收藏
页码:4 / 7
页数:4
相关论文
共 50 条
  • [41] LICENSING - A WAY TO BRING TECHNOLOGY TO MARKET
    ROBERTSON, AO
    ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 1993, 205 : 1 - CHAL
  • [42] BYOD — Bring Your Own Device
    Georg Disterer
    Carsten Kleiner
    HMD Praxis der Wirtschaftsinformatik, 2013, 50 (2) : 92 - 100
  • [43] Letters to medical devices: a case study on the medical device user requirements of adolescents with type 1 diabetes
    McCarthy, Gillian M.
    Ramirez, Edgar R. Rodriguez
    Robinson, Brian J.
    BEHAVIOUR & INFORMATION TECHNOLOGY, 2021, 40 (01) : 39 - 48
  • [44] MARKET ACCESS OF IMPLANTABLE MEDICAL DEVICES: EVIDENTIARY REQUIREMENTS ACROSS GLOBAL MARKETS
    Chawla, A. S.
    Spinner, D. S.
    Ransom, J. F.
    Doyle, J.
    Faulkner, E. C.
    VALUE IN HEALTH, 2013, 16 (07) : A328 - A328
  • [45] Consolidation and maturation of the orthopaedic medical device market between 1999 and 2015
    Nicolas S. Piuzzi
    Mitchell Ng
    Simon Song
    Stephen Bigach
    Anton Khlopas
    Sebastian Salas-Vega
    Michael A. Mont
    European Journal of Orthopaedic Surgery & Traumatology, 2019, 29 : 759 - 766
  • [46] Consolidation and maturation of the orthopaedic medical device market between 1999 and 2015
    Piuzzi, Nicolas S.
    Ng, Mitchell
    Song, Simon
    Bigach, Stephen
    Khlopas, Anton
    Salas-Vega, Sebastian
    Mont, Michael A.
    EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY AND TRAUMATOLOGY, 2019, 29 (04): : 759 - 766
  • [47] Clinical evaluation requirements under the new European Union medical device regulation
    Hernandez, Gloria Hernandez
    REC-INTERVENTIONAL CARDIOLOGY, 2024, 6 (04):
  • [48] Analysis of safety reporting requirements during medical device clinical trials in Japan
    Kentaro Azuma
    Hiroshi Iseki
    Journal of Artificial Organs, 2013, 16 : 234 - 241
  • [49] Clinical evaluation requirements under the new European Union medical device regulation
    Hernandez, Gloria Hernandez
    REC-INTERVENTIONAL CARDIOLOGY, 2024, 6 (04):
  • [50] Analysis of safety reporting requirements during medical device clinical trials in Japan
    Azuma, Kentaro
    Iseki, Hiroshi
    JOURNAL OF ARTIFICIAL ORGANS, 2013, 16 (02) : 234 - 241