@article{7ca99526d827458fb50b8c30e39782df,
title = "Software to manage regulatory workflows for medical device development at academic medical centers: A critical gap",
keywords = "Medical device development, artificial intelligence, regulatory requirements, research infrastructure, software",
author = "Lynn Rose and Jennifer McCaney and Gaurav Dave and Brownley, {Kimberly A.} and David Sheridan and Payal Shah and Grzegorz Zapotoczny and Juan Espinoza",
note = "Funding Information: The project described was supported by the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Numbers UL1TR002489, UL1TR001855, UL1TR000130, UL1TR001881, UL1TR002319, KL2TR002317, and TL1TR002318. This work was also supported by the Food and Drug Administration under award number P50FD006425 for The West Coast Consortium for Technology & Innovation in Pediatrics. The funding sources were not involved in the development of this manuscript or in the decision to submit the paper for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the FDA or the NIH. ",
year = "2023",
month = feb,
day = "15",
doi = "10.1017/cts.2023.2",
language = "English (US)",
volume = "7",
journal = "Journal of Clinical and Translational Science",
issn = "2059-8661",
publisher = "Cambridge University Press",
number = "1",
}