AIMC Journal:
The International journal of risk & safety in medicine
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Reframing risk management for AI-enabled medical devices: A dual-layer risk governance framework.
The International journal of risk & safety in medicine
Aug 13, 2026
BackgroundAI-enabled medical devices introduce dynamic, data-dependent risks that challenge traditional safety-risk management frameworks. While ISO 14971, AAMI CR34971, and the EU Artificial Intelligence Act each address elements of device safety an...
Drug-induced multisystem syndromes: An overlooked challenge in pharmacovigilance.
The International journal of risk & safety in medicine
Jun 15, 2026
BackgroundDrug-Induced Multisystem Syndromes (DIMS) represent a clinically significant yet under-recognized group of delayed immune-mediated adverse drug reactions characterized by heterogeneous clinical presentations, diagnostic uncertainty, and sub...
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