Concepedia

Quality System Regulation

Quality System Regulation is a regulatory framework that specifies the methods, requirements, and controls for designing, manufacturing, and testing medical devices to ensure their safety and effectiveness, distinguishing it from other regulatory standards by its comprehensive oversight of the entire device lifecycle under the authority of the U.S. Food and Drug Administration.

32

Publications

1.2K

Citations

91

Authors

58

Institutions

Publications per year

2017–2026

11

Variants

Qsr

Parents

Children

Publications

32

To regulate or not to regulate? What to do with more toxic disinfection by-products?

Susan D. Richardson, Michael J. Plewa · Journal of environmental chemical engineering · 2020 · 209 citations

, , +12

Clinical Laboratory Improvement Amendments of 1988

Thomas P. Christensen · 2002 · 136 citations

, , +11

A Path to Better-Quality mHealth Apps

Richard S. Larson · JMIR mhealth and uhealth · 2018 · 123 citations · Full text

, , +15

Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)--HCFA. Final rule with comment period.

PubMed · 1992 · 86 citations

, , +13

Minimum quality standards as a barrier to innovation

John W. Maxwell · Economics Letters · 1998 · 85 citations

, , +12

1–5 of 32

Authors

91

  1. MK
    Minjune Kim

    Dana-Farber Brigham Cancer Center, United States

    2 publications · 50 citations

    2

    h-index

  2. PK
    Peter K. Sorger

    Harvard University, United States

    2 publications · 50 citations

    2

    h-index

  3. SH
    Sherry H. Yu

    Harvard University, United States

    2 publications · 50 citations

    2

    h-index

  4. DP
    Deborah Plana

    Harvard University, United States

    2 publications · 50 citations

    2

    h-index

  5. MM
    Mary M. Carmack

    Boston Children's Hospital, United States

    2 publications · 50 citations

    2

    h-index

1–5 of 91

Institutions

58

  1. Brigham and Women's Hospital

    Boston, United States

    2 h-index

    5 publications

    118 citations

  2. Yale University

    New Haven, United States

    2 h-index

    2 publications

    50 citations

  3. Tsinghua University

    Beijing, China

    2 h-index

    4 publications

    100 citations

  4. Johnson & Johnson (United States)

    New Brunswick, United States

    2 h-index

    3 publications

    47 citations

  5. Ludwig Cancer Research

    New York, United States

    2 h-index

    4 publications

    100 citations

  6. Harvard–MIT Division of Health Sciences and Technology

    Cambridge, United States

    2 h-index

    4 publications

    100 citations

  7. Harvard University

    Cambridge, United States

    2 h-index

    25 publications

    618 citations

  8. Dana-Farber Brigham Cancer Center

    Boston, United States

    2 h-index

    2 publications

    50 citations

1–8 of 58

Venues

  1. PubMed

    Repository · 7 publications · 245 citations

    6

    h-index

  2. International Medical Science Research Journal

    IMSRJ · 1 publications · 25 citations

    1

    h-index

  3. Key engineering materials

    KEM · Book series · 1 publications · 11 citations

    1

    h-index

  4. Economics Letters

    1 publications · 85 citations

    1

    h-index

  5. International Journal of Production Economics

    1 publications · 41 citations

    1

    h-index

1–5