This work proposes nine operational measures - covering transparency-oriented risk and change control, traceability, subgroup and independent validation, usability-based explainability, calibrated clinical evaluation, structured labeling, version-controlled updates, and regulated end-of-life data handling - to support...
E. Bianchini, L. Billeci, Noemi Conditi et al.· Expert Review of Medical Dev...· 0 citations
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