Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives

Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen

Research output: Contribution to journalArticleScientificpeer-review

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Abstract

Despite the immense potential of artificial intelligence (AI)-powered medical devices to revolutionize health care, concerns regarding their safety in life-critical applications remain. This article proposes extending the general idea of AI lifecycle with regulatory activities relevant to AI-enabled medical systems.
Original languageEnglish
Pages (from-to)24-34
Number of pages11
JournalComputer
Volume57
Issue number9
DOIs
Publication statusPublished - Sept 2024
Publication typeA1 Journal article-refereed

Keywords

  • Industries
  • Medical devices
  • Europe
  • Medical services
  • Safety
  • Artificial intelligence

Publication forum classification

  • Publication forum level 2

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