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

Tuomas Granlund; Vlad Stirbu; Tommi Mikkonen

doi:10.1109/MC.2024.3414368

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

Tuomas Granlund
, Vlad Stirbu
, Tommi Mikkonen

Computing Sciences

Research output: Contribution to journal › Article › Scientific › peer-review

1 Citation (Scopus)

17 Downloads (Pure)

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 language	English
Pages (from-to)	24-34
Number of pages	11
Journal	Computer
Volume	57
Issue number	9
DOIs	https://doi.org/10.1109/MC.2024.3414368
Publication status	Published - Sept 2024
Publication type	A1 Journal article-refereed

Keywords

Industries
Medical devices
Europe
Medical services
Safety
Artificial intelligence

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Publication forum level 2

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10.1109/MC.2024.3414368Licence: CC BY

Toward_a_Regulatory-Compliant_Lifecycle_for_Artificial-Intelligence-Based_Medical_Devices_in_the_European_Union_Industry_PerspectivesFinal published version, 2.08 MBLicence: CC BY

https://urn.fi/URN:NBN:fi:tuni-2024122011477Licence: CC BY

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

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.",

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KW - Europe

KW - Medical services

KW - Safety

KW - Artificial intelligence

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

Abstract

Keywords

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