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Artificial intelligence in medical device software and high-risk medical devices–a review of definitions, expert recommendations and regulatory initiatives

  • Alan G. Fraser*
  • , Elisabetta Biasin
  • , Bart Bijnens
  • , Nico Bruining
  • , Enrico G. Caiani
  • , Koen Cobbaert
  • , Rhodri H. Davies
  • , Stephen H. Gilbert
  • , Leo Hovestadt
  • , Erik Kamenjasevic
  • , Zuzanna Kwade
  • , Gearóid McGauran
  • , Gearóid O’Connor
  • , Baptiste Vasey
  • , Frank E. Rademakers
    • *Corresponding author for this work
  • University Hospital of Wales
  • KU Leuven
  • August Pi i Sunyer Biomedical Research Institute
  • Polytechnic University of Milan
  • Philips Research
  • University College London
  • University of Dresden
  • Elekta AB
  • Dedalus HealthCare GmbH
  • Health Products Regulatory Authority
  • University of Oxford

Research output: Contribution to journal › Review article › Academic › peer-review

59 Citations (Scopus)
457 Downloads (Pure)

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Medicine and Dentistry