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Expert Review of Medical Devices Volume 20, 2023 - Issue 6
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Review

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

Alan G Frasera University Hospital of Wales, School of Medicine, Cardiff University, Heath Park, Cardiff, U.K;m KU Leuven, Leuven, BelgiumCorrespondence[email protected] [email protected]
ORCID Iconhttps://orcid.org/0000-0001-7083-6995View further author information
ORCID Icon,
Elisabetta Biasinb Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, BelgiumView further author information
,
Bart Bijnensc Engineering Sciences, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, SpainView further author information
,
Nico Bruiningd Department of Clinical and Experimental Information processing (Digital Cardiology), Erasmus Medical Center, Thoraxcenter, Rotterdam, the NetherlandsView further author information
,
Enrico G Caianie Department of Electronics, Information and Biomedical Engineering, Politecnico di Milano, Milan, ItalyView further author information
,
Koen Cobbaertf Philips, Brussels, BelgiumORCID Iconhttps://orcid.org/0000-0001-5346-531XView further author information
ORCID Icon,
Rhodri H Daviesg Institute of Cardiovascular Science, University College London, London, U.KView further author information
,
Stephen H Gilberth Technische Universität Dresden, Else Kröner Fresenius Center for Digital Health, Dresden, GermanyView further author information
,
Leo Hovestadti Elekta, Stockholm, SwedenView further author information
,
Erik Kamenjasevicb Centre for IT & IP Law (CiTiP), KU Leuven, Leuven, BelgiumORCID Iconhttps://orcid.org/0000-0002-5160-7625View further author information
ORCID Icon,
Zuzanna Kwadej Dedalus HealthCare GmbH, Bonn, GermanyView further author information
,
Gearóid McGaurank Health Products Regulatory Authority, Dublin, IrelandView further author information
,
Gearóid O’Connork Health Products Regulatory Authority, Dublin, IrelandView further author information
,
Baptiste Vaseyl Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UKView further author information
&
Frank E Rademakersm KU Leuven, Leuven, BelgiumView further author information
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Pages 467-491 | Received 30 Oct 2022, Accepted 22 Feb 2023, Published online: 08 May 2023

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