Adverse event reporting and regulatory analysis of pediatric cardiac assist devices

• Songyining Ding,

  Roles Formal analysis, Investigation, Visualization, Writing – original draft

  Affiliation School of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China

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• Susmitha Wunnava,

  Roles Conceptualization, Data curation, Methodology, Resources, Validation

  Affiliation Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts, United States of America

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• Gaite Liu,

  Roles Conceptualization, Methodology, Writing – review & editing

  Affiliation Shanghai Institute of Medical Device Testing, Shanghai, China

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• Hongyi Yu,

  Roles Methodology, Validation

  Affiliation Shanghai Institute of Medical Device Testing, Shanghai, China

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• Sheng Hu,

  Roles Supervision, Validation

  Affiliation Shanghai Institute of Medical Device Testing, Shanghai, China

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• Yaohua Li,

  Roles Resources, Supervision, Validation

  Affiliation Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai, China

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• Xinyan Zhang,

  Roles Supervision, Validation

  Affiliation Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai, China

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• Peiming Zhang,

  Roles Supervision, Validation

  Affiliation School of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China

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• Yunzhang Cheng,

  Roles Supervision, Validation

  Affiliation School of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China

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• Florence T. Bourgeois,

  Roles Methodology, Supervision, Validation

  Affiliations Harvard-MIT Center for Regulatory Science, Harvard Medical School, Boston, Massachusetts, United States of America, Computational Health Informatics Program, Boston Children’s Hospital, Boston, Massachusetts, United States of America

  https://orcid.org/0000-0001-7798-4560

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• Xun Liu

  Roles Investigation, Methodology, Validation

  * E-mail: liuxun_hust@126.com

  Affiliations Shanghai Institute of Medical Device Testing, Shanghai, China, NMPA Center for Innovation and Research in Regulatory Science, Shanghai, China

  https://orcid.org/0000-0002-0691-4589

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