Concepedia

Device Regulation

Device Regulation is a regulatory framework within the broader field of Regulatory Science that specifically governs the development, approval, monitoring, and post-market oversight of medical devices to ensure their safety, efficacy, and quality throughout their lifecycle.

490

Publications

21.1K

Citations

1.6K

Authors

754

Institutions

Publications per year

2017–2026

194

Variants

Medical Device RegulationMedical Device Regulations

Parents

Children

Publications

490

The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

Stan Benjamens, Pranavsingh Dhunnoo, Bertalan Meskó · npj Digital Medicine · 2020 · 1.1K citations · Full text

, , +9

National Healthcare Safety Network (NHSN) report, data summary for 2012, Device-associated module

Margaret A. Dudeck, Lindsey M. Weiner, Katherine Allen‐Bridson et al. · American Journal of Infection Control · 2013 · 658 citations · Full text

, , +15

Review of the Current State of UAV Regulations

Claudia Stöcker, Rohan Bennett, Francesco Nex et al. · Remote Sensing · 2017 · 594 citations · Full text

, , +11

How medical AI devices are evaluated: limitations and recommendations from an analysis of FDA approvals

Eric Q. Wu, Kevin Wu, Roxana Daneshjou et al. · Nature Medicine · 2021 · 462 citations

, , +14

National Healthcare Safety Network report, data summary for 2013, Device-associated Module

Margaret A. Dudeck, Jonathan R. Edwards, Katherine Allen‐Bridson et al. · American Journal of Infection Control · 2015 · 377 citations · Full text

, , +13

1–5 of 490

Authors

1.6K

  1. AS
    Aaron S. Kesselheim

    Brigham and Women's Hospital, United States

    9 publications · 862 citations

    9

    h-index

  2. FM
    Fergal McCaffery

    Dundalk Institute of Technology, Ireland

    8 publications · 134 citations

    8

    h-index

  3. JS
    Joseph S. Ross

    Yale University, United States

    6 publications · 173 citations

    6

    h-index

  4. AG
    Alan G. Fraser

    Cardiff University, United Kingdom

    8 publications · 336 citations

    6

    h-index

  5. SS
    Sanket S. Dhruva

    University of California, San Francisco, United States

    6 publications · 122 citations

    6

    h-index

1–5 of 1.6K

Institutions

754

  1. Harvard University

    Cambridge, United States

    19 h-index

    39 publications

    2.7K citations

  2. Center for Devices and Radiological Health

    Rockville, United States

    14 h-index

    100 publications

    2.8K citations

  3. United States Food and Drug Administration

    Silver Spring, United States

    14 h-index

    100 publications

    3.3K citations

  4. Brigham and Women's Hospital

    Boston, United States

    14 h-index

    35 publications

    1.8K citations

  5. University of Oxford

    Oxford, United Kingdom

    11 h-index

    34 publications

    2K citations

  6. University of Pennsylvania

    Philadelphia, United States

    9 h-index

    17 publications

    1K citations

  7. Yale University

    New Haven, United States

    9 h-index

    19 publications

    645 citations

  8. Beth Israel Deaconess Medical Center

    Boston, United States

    7 h-index

    8 publications

    726 citations

1–8 of 754

Venues

  1. PubMed

    Repository · 27 publications · 562 citations

    16

    h-index

  2. New England Journal of Medicine

    NEJM · 13 publications · 1.2K citations

    13

    h-index

  3. BMJ

    12 publications · 432 citations

    11

    h-index

  4. JAMA

    10 publications · 550 citations

    10

    h-index

  5. SSRN Electronic Journal

    Repository · 7 publications · 208 citations

    7

    h-index

1–5