Concepedia

Device Risk Classification

Device Risk Classification is a regulatory science construct that categorizes medical devices based on their potential risk to patient safety and public health, differentiating them according to the level of control necessary to ensure safety and effectiveness.

53

Publications

4.2K

Citations

178

Authors

83

Institutions

Publications per year

2017–2026

18

Variants

Medical Device Risk Classification

Parents

Publications

53

Differences in Tachyarrhythmia Detection and Implantable Cardioverter Defibrillator Therapy by Primary or Secondary Prevention Indication in Cardiac Resynchronization Therapy Patients

Bruce L. Wilkoff, MIKE HESS, James B. Young et al. · Journal of Cardiovascular Electrophysiology · 2004 · 833 citations

, , +14

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

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

Regulation of Medical Devices in the United States and European Union

Daniel B. Kramer, Shuai Xu, Aaron S. Kesselheim · New England Journal of Medicine · 2012 · 263 citations

, , +15

National Healthcare Safety Network (NHSN) Report, data summary for 2010, device-associated module

Margaret A. Dudeck, Teresa Horan, Kelly Peterson et al. · American Journal of Infection Control · 2011 · 258 citations · Full text

, , +15

1–5 of 53

Authors

178

  1. JR
    Jonathan R. Edwards

    Centers for Disease Control and Prevention, United States

    5 publications · 1.6K citations

    5

    h-index

  2. DA
    Daniel A. Pollock

    Centers for Disease Control and Prevention, United States

    5 publications · 1.6K citations

    5

    h-index

  3. KA
    Katherine Allen‐Bridson

    Centers for Disease Control and Prevention, United States

    5 publications · 1.6K citations

    5

    h-index

  4. MA
    Margaret A. Dudeck

    Centers for Disease Control and Prevention, United States

    5 publications · 1.6K citations

    5

    h-index

  5. KP
    Kelly Peterson

    Centers for Disease Control and Prevention, United States

    5 publications · 1.6K citations

    5

    h-index

1–5 of 178

Institutions

83

  1. United States Department of Health and Human Services

    Washington, United States

    5 h-index

    30 publications

    7.9K citations

  2. Center for Devices and Radiological Health

    Rockville, United States

    3 h-index

    3 publications

    50 citations

  3. Centers for Disease Control and Prevention

    Atlanta, United States

    3 h-index

    24 publications

    5.9K citations

  4. National Center for Emerging and Zoonotic Infectious Diseases

    Atlanta, United States

    3 h-index

    7 publications

    2.3K citations

  5. Stanford University

    Stanford, United States

    2 h-index

    5 publications

    150 citations

  6. Harvard University

    Cambridge, United States

    2 h-index

    3 publications

    789 citations

  7. University of Cambridge

    Cambridge, United Kingdom

    2 h-index

    4 publications

    126 citations

  8. Austrian Institute for Health Technology Assessment GmbH

    Vienna, Austria

    2 h-index

    3 publications

    76 citations

1–8 of 83

Venues

  1. PubMed

    Repository · 5 publications · 86 citations

    5

    h-index

  2. American Journal of Infection Control

    AJIC · 5 publications · 1.6K citations

    5

    h-index

  3. 2

    h-index

  4. Journal of Clinical Engineering

    2 publications · 34 citations

    2

    h-index

  5. New England Journal of Medicine

    NEJM · 2 publications · 329 citations

    2

    h-index

1–5