Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives
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.
Authors
- Vlad Stirbu (ORCID: https://orcid.org/0000-0001-9462-5922)
- Tuomas Granlund (ORCID: https://orcid.org/0000-0003-3955-0926)
- Tommi Mikkonen (ORCID: https://orcid.org/0000-0002-8540-9918)
Publication Details
- Journal
- Computer
- Published
- 2024-08-30
- DOI
- https://doi.org/10.1109/mc.2024.3414368
- Citations
- 2
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 0.24