The U.S. Food and Drug Administration has released updated guidance for AI-enabled medical devices that reshapes how manufacturers must approach the
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The U.S. Food and Drug Administration published a notice in the Federal Register on May 1, 2026, announcing its intent
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Missing your MDEL renewal deadline puts your entire Canadian market access at risk. Under the Medical Devices Regulations (SOR/98-282), all Medical Device
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Artificial intelligence (AI) is reshaping the medical device industry, making diagnostics, treatment planning, and patient monitoring more efficient than ever.
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As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
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