[Research on Current Situation of Quality Management of Artificial Intelligence Medical Device Enterprises].

Journal: Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
Published Date: Apr 8, 2021

Abstract

OBJECTIVE: To understand the current situation of artificial intelligence production enterprise quality management system, so as to provide reference basis for the research and standardization of Artificial Intelligence Medical Device (AIMD) product quality management.

Authors

  • Yi Liu
    Department of Interventional Therapy, Ningbo No. 2 Hospital, Ningbo, China.
  • Hao Wang
    Department of Cardiology, Second Medical Center, Chinese PLA General Hospital, Beijing, China.
  • Shu Li
    China Medical University College of Health Management, Shenyang 110122, Liaoning Province, China.
  • Wei Zhang
    The First Affiliated Hospital of Nanchang University, Nanchang, China.
  • Yubo Fan
    State Key Laboratory of Software Development Environment, Key Laboratory of Biomechanics and Mechanobiology of Ministry of Education, Beihang University, Beijing, China. yubofan@buaa.edu.cn.

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