Enrico G. Caiani

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

2023 · 58 Zit. · Expert Review of Medical Devices

CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software

2025 · 8 Zit. · npj Digital Medicine

Classification grid and evidence matrix for evaluating digital medical devices under the European union landscape

2025 · 5 Zit. · npj Digital Medicine