For a MLMDs, effective transparency ensures that information that could impact patient risks and outcomes is communicated to all interacting with the device.| U.S. Food and Drug Administration
EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.| European Medicines Agency (EMA)
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Information about CDRH's Digital Health Program| U.S. Food and Drug Administration