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2021 - Mobile Apps as Medical Devices



VenueOnline event, USA - United States USA - United States

KeywordsMedical devices; Mobile medical apps; Software validation


Topics/Call fo Papers

Mobile Health Apps / Functions – What are they?
SaMD and SiMD
FDA’s Functionality vs. Platform enforcement approach
Intended Use – not just a term
Software functions that are, or are NOT, a “device”
FDA’s regulatory approach; Examples
Design, manufacturing and additional requirements
Cybersecurity requirements
Validation and unique documentation requirements

Last modified: 2021-06-28 16:47:07