Work

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

Year: 2024

Type: article

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.

Source: Computer

DOI: 10.1109/mc.2024.3414368

Authors: Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen

Institution: University of Jyväskylä

Language: English

Topic: Safety Systems Engineering in Autonomy

Subfield: Safety, Risk, Reliability and Quality

Field: Engineering

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: hybrid

Estimated APC paid: $2,995