Credibility assessment of in silico clinical trials for medical devices

• Pras Pathmanathan ,

  Roles Conceptualization, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing

  * E-mail: pras.pathmanathan@fda.hhs.gov

  Affiliation Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, United States of America

  https://orcid.org/0000-0003-2111-6689

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• Kenneth Aycock,

  Roles Investigation, Methodology, Writing – original draft, Writing – review & editing

  Affiliation Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Andreu Badal,

  Roles Investigation, Methodology, Writing – original draft, Writing – review & editing

  Affiliation Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Ramin Bighamian,

  Roles Investigation, Methodology, Writing – original draft, Writing – review & editing

  Affiliation Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Jeff Bodner,

  Roles Investigation, Methodology, Writing – original draft, Writing – review & editing

  Affiliation Medtronic, PLC., Minneapolis, Minnesota, United States of America

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• Brent A. Craven,

  Roles Investigation, Methodology, Writing – original draft, Writing – review & editing

  Affiliation Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Steven Niederer

  Roles Investigation, Methodology, Writing – original draft, Writing – review & editing

  Affiliations National Heart and Lung Institute, Imperial College, London, United Kingdom, The Alan Turing Institute, London, United Kingdom

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