Software to manage regulatory workflows for medical device development at academic medical centers: A critical gap

被引：0
|
作者：
Rose, Lynn [1 ]
McCaney, Jennifer [2 ]
Dave, Gaurav [3 ,4 ,5 ]
Brownley, Kimberly A. [4 ,6 ]
Sheridan, David [7 ]
Shah, Payal [8 ,9 ]
Zapotoczny, Grzegorz [9 ]
Espinoza, Juan [8 ,10 ]
机构：
[1] Univ Washington, Dept Pharm, Seattle, WA USA
[2] Univ Calif Los Angeles, Anderson Sch Management, Los Angeles, CA USA
[3] Univ North Carolina Chapel Hill, Dept Med, Chapel Hill, NC USA
[4] Univ North Carolina Chapel Hill, North Carolina Translat & Clin Sci Inst, Chapel Hill, NC USA
[5] Univ North Carolina Chapel Hill, Ctr Hlth Equ Res, Chapel Hill, NC USA
[6] Univ North Carolina Chapel Hill, Dept Psychiat, Chapel Hill, NC USA
[7] Oregon Hlth &Science Univ, Dept Emergency Med, Portland, OR USA
[8] Childrens Hosp Angeles, West Coast Consortium Technol & Innovat Pediat, Los Angeles, CA USA
[9] Childrens Hosp Angeles, Div Gen Pediat, Los Angeles, CA USA
[10] USC, Dept Pediat, Keck Sch Med,Clin Pediat, Div Gen Pediat, 4650 Sunset Blvd, Mailstop 76, Los Angeles, CA 90027 USA
来源：
JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE | 2023年 / 7卷 / 01期
基金：
美国国家卫生研究院;
关键词：
Medical device development; research infrastructure; regulatory requirements; software; artificial intelligence; PRODUCT DEVELOPMENT;
D O I：
10.1017/cts.2023.2
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
引用
收藏
页数：3
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