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Expert articles on MDR, ISO 13485, IEC 62304, AI Act and more — by the team behind Gordios.
In medicine, a decision without traceability is a contestable decision. AI is making its way into medical devices, and its decisions must be just as traceable and explainable as a human decision.
Find out how the UDI system ensures the traceability, safety and compliance of medical devices worldwide.
The question may seem trivial: we all know what a medical device is... or don't we? The regulatory reality, however, is a little more subtle.
