Concepedia

Medical Device Evaluation

Medical Device Evaluation is a systematic academic and clinical inquiry process that constitutes the assessment of medical devices for safety, efficacy, performance, and regulatory compliance within intended healthcare environments, distinguishing it from broader device development or management by its focused analytical and evidence-based appraisal prior to or during clinical adoption.

864

Publications

35.9K

Citations

4.3K

Authors

1.6K

Institutions

Publications per year

2017–2026

333

Parents

Children

Publications

864

Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults

Eoin OʼBrien, Thomas G. Pickering, Roland Asmar et al. · Blood Pressure Monitoring · 2002 · 744 citations · Full text

, , +16

Using usability heuristics to evaluate patient safety of medical devices

Jiajie Zhang, Todd R. Johnson, Vimla L. Patel et al. · Journal of Biomedical Informatics · 2003 · 589 citations

, , +15

Efficacy and Safety of Automatic Remote Monitoring for Implantable Cardioverter-Defibrillator Follow-Up

Niraj Varma, Andrew E. Epstein, Anand Irimpen et al. · Circulation · 2010 · 586 citations

, , +16

Long-Term Outcome After ICD and CRT Implantation and Influence of Remote Device Follow-Up

Leslie A. Saxon, David L. Hayes, F. Roosevelt Gilliam et al. · Circulation · 2010 · 518 citations · Full text

, , +15

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

1–5 of 864

Authors

4.3K

  1. OC
    Oriana Ciani

    Bocconi University, Italy

    9 publications · 370 citations

    9

    h-index

  2. AG
    Alan G. Fraser

    Cardiff University, United Kingdom

    11 publications · 493 citations

    9

    h-index

  3. NV
    Niraj Varma

    Cleveland Clinic, United States

    9 publications · 1.2K citations

    9

    h-index

  4. RT
    Rosanna Tarricone

    Bocconi University, Italy

    9 publications · 479 citations

    9

    h-index

  5. AA
    Angelo Auricchio

    Epatocentro Ticino, Switzerland

    8 publications · 584 citations

    8

    h-index

1–5 of 4.3K

Institutions

1.6K

  1. Harvard University

    Cambridge, United States

    23 h-index

    62 publications

    6.6K citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    22 h-index

    104 publications

    6.8K citations

  3. Center for Devices and Radiological Health

    Rockville, United States

    20 h-index

    117 publications

    4.4K citations

  4. Cleveland Clinic

    Cleveland, United States

    18 h-index

    74 publications

    7.8K citations

  5. Brigham and Women's Hospital

    Boston, United States

    17 h-index

    32 publications

    2.3K citations

  6. Medtronic (United States)

    Minneapolis, United States

    17 h-index

    50 publications

    2.7K citations

  7. University College London

    London, United Kingdom

    15 h-index

    34 publications

    1.7K citations

  8. Beth Israel Deaconess Medical Center

    Boston, United States

    15 h-index

    27 publications

    4.1K citations

1–8 of 1.6K

Venues

  1. PubMed

    Repository · 33 publications · 1.2K citations

    20

    h-index

  2. EP Europace

    20 publications · 1.2K citations

    18

    h-index

  3. 17

    h-index

  4. Pacing and Clinical Electrophysiology

    PACE · 22 publications · 775 citations

    16

    h-index

  5. Heart Rhythm

    15 publications · 1.2K citations

    14

    h-index

1–5