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

页数：3

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