Medical device software regulation: An industry perspective

被引:0
|
作者
Simons, D
机构
来源
FOOD AND DRUG LAW JOURNAL | 1997年 / 52卷 / 02期
关键词
D O I
暂无
中图分类号
TS2 [食品工业];
学科分类号
0832 ;
摘要
引用
收藏
页码:189 / 192
页数:4
相关论文
共 50 条
  • [1] FDA software policy and regulation of medical device software
    Crumpler, ES
    Rudolph, H
    [J]. FOOD AND DRUG LAW JOURNAL, 1997, 52 (04): : 511 - 516
  • [2] A SURGEONS PERSPECTIVE OF MEDICAL DEVICE REGULATION
    BRANTIGAN, JW
    [J]. JOURNAL OF SPINAL DISORDERS, 1995, 8 (05): : 396 - 412
  • [3] AN FDA PERSPECTIVE ON MEDICAL DEVICE REGULATION
    SHORE, ML
    MCDONNELL, EJ
    [J]. JOURNAL OF MEDICAL ENGINEERING & TECHNOLOGY, 1986, 10 (01) : A124 - A131
  • [4] Economic a Social Perspective of Medical Device Industry
    Maresova, Petra
    Kuca, Kamil
    [J]. INNOVATION VISION 2020: FROM REGIONAL DEVELOPMENT SUSTAINABILITY TO GLOBAL ECONOMIC GROWTH, VOL I-VI, 2015, : 3357 - 3361
  • [5] Digital health - Software as a medical device in focus of the medical device regulation (MDR)
    Becker, Kurt
    Lipprandt, Myriam
    Roehrig, Rainer
    Neumuth, Thomas
    [J]. IT-INFORMATION TECHNOLOGY, 2019, 61 (5-6): : 211 - 218
  • [6] A software process improvement lifecycle framework for the medical device industry
    McCaffery, F
    McFall, D
    Donnelly, P
    Wilkie, FG
    Sterritt, R
    [J]. 12th IEEE International Conference and Workshops on the Engineering of Computer-Based Systems, Proceedings, 2005, : 273 - 280
  • [7] The medical device regulation (MDR) from a dental perspective
    Mohn, Dirk
    Zehnder, Matthias
    [J]. FRONTIERS IN DENTAL MEDICINE, 2023, 4
  • [8] The EU medical device regulation: Implications for artificial intelligence-based medical device software in medical physics
    Beckers, R.
    Kwade, Z.
    Zanca, F.
    [J]. PHYSICA MEDICA-EUROPEAN JOURNAL OF MEDICAL PHYSICS, 2021, 83 : 1 - 8
  • [9] An Oversight in Oversight Reconciling the Medical Device Industry, Clinicians, and Regulation
    Landeen, Kelly C.
    Langerman, Alexander
    Maldonado, Fabien
    [J]. CHEST, 2022, 161 (01) : 300 - 302
  • [10] Medical Device Software Development - A Perspective from a Lean Manufacturing Plant
    Cawley, Oisin
    Richardson, Ita
    Wang, Xiaofeng
    [J]. SOFTWARE PROCESS IMPROVEMENT AND CAPABILITY DETERMINATION, 2011, 155 : 84 - 96