Concepedia

Software Conformity Assessment

Software Conformity Assessment is a formal evaluation process within medical device regulation that determines whether a software-based medical device or software component thereof fulfills the essential safety, performance, and quality requirements of applicable regulatory standards and directives, specifically distinguishing it from general software validation by its legally mandated, standards-driven, and audit-traceable nature.

42

Publications

1.1K

Citations

89

Authors

42

Institutions

Publications per year

2017–2026

9

Parents

Publications

42

capAI - A Procedure for Conducting Conformity Assessment of AI Systems in Line with the EU Artificial Intelligence Act

Luciano Floridi, Matthias Holweg, Mariarosaria Taddeo et al. · SSRN Electronic Journal · 2022 · 149 citations · Full text

, , +16

Evaluating software engineering standards

Shari Lawrence Pfleeger, Norman Fenton, Stanley R. Page · Computer · 1994 · 75 citations

, , +16

Software evaluation using the 9241 evaluator

Reinhard Oppermann, Harald Reiterer · Behaviour and Information Technology · 1997 · 57 citations · Full text

, , +12

Conformance testing: Architectures and test sequences

Behçet Sarikaya · Computer Networks and ISDN Systems · 1989 · 46 citations

, , +9

The Role of AI Driven Clinical Research in Medical Device Development: A Data Driven Approach to Regulatory Compliance and Quality Assurance

Sai Teja Nuka · Global Journal of Medical Case Reports · 2022 · 45 citations · Full text

, , +17

1–5 of 42

Authors

89

  1. FM
    Fergal McCaffery

    Dundalk Institute of Technology, Ireland

    7 publications · 139 citations

    7

    h-index

  2. AD
    Alec Dorling

    Dundalk Institute of Technology, Ireland

    5 publications · 95 citations

    5

    h-index

  3. FG
    F. G. Wilkie

    University of Ulster, United Kingdom

    2 publications · 34 citations

    2

    h-index

  4. PD
    Peter Donnelly

    St. Vincent's University Hospital, Ireland

    2 publications · 34 citations

    2

    h-index

  5. AK
    Aaron K. Massey

    Georgia Institute of Technology, United States

    2 publications · 31 citations

    2

    h-index

1–5 of 89

Institutions

42

  1. Dundalk Institute of Technology

    Dundalk, Ireland

    7 h-index

    15 publications

    239 citations

  2. North Carolina State University

    Raleigh, United States

    2 h-index

    6 publications

    168 citations

  3. United States Food and Drug Administration

    Silver Spring, United States

    1 h-index

    2 publications

    54 citations

  4. University of Kansas

    Lawrence, United States

    1 h-index

    1 publications

    15 citations

  5. University of Ulster

    Coleraine, United Kingdom

    1 h-index

    2 publications

    24 citations

  6. Brandeis University

    Waltham, United States

    1 h-index

    1 publications

    27 citations

  7. Communication University of China

    Beijing, China

    1 h-index

    1 publications

    32 citations

  8. University of Bonn

    Bonn, Germany

    1 h-index

    1 publications

    22 citations

1–8 of 42

Venues

  1. 3

    h-index

  2. Computer

    1 publications · 75 citations

    2

    h-index

  3. Behaviour and Information Technology

    2 publications · 79 citations

    2

    h-index

  4. Journal of Software Evolution and Process

    JSEP · 2 publications · 33 citations

    2

    h-index

  5. IEEE Transactions on Software Engineering

    TSE · 2 publications · 23 citations

    2

    h-index

1–5