Published on in Vol 25 (2023)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/47505, first published .
Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis

Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis

Innovation Process and Industrial System of US Food and Drug Administration–Approved Software as a Medical Device: Review and Content Analysis

Authors of this article:

Jiakan Yu1 Author Orcid Image ;   Jiajie Zhang2 Author Orcid Image ;   Shintaro Sengoku1, 3 Author Orcid Image

Jiakan Yu   1 , MA ;   Jiajie Zhang   2 , MA ;   Shintaro Sengoku   1, 3 , PhD

1 Department of Technology and Innovation Management, School of Environment and Society, Tokyo Institute of Technology, Tokyo, Japan

2 Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Tokyo, Japan

3 Department of Innovation Science, School of Environment and Society, Tokyo Institute of Technology, Tokyo, Japan

Corresponding Author:

  • Shintaro Sengoku, PhD
  • Department of Innovation Science
  • School of Environment and Society
  • Tokyo Institute of Technology
  • Tokyo Campus Innovation Center 9th Floor Room 908N
  • 3-3-6 Shibaura, Minato-ku
  • Tokyo, 108-0023
  • Japan
  • Phone: 81 03 3454 8907
  • Email: sengoku.s.aa@m.titech.ac.jp