The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...
Forbes contributors publish independent expert analyses and insights. Dr. Lance B. Eliot is a world-renowned AI scientist and consultant. In today’s column, I examine the recently published FDA ...
Medical Device Network on MSN
The medical device manufacturing crunch
With Covid accelerating time-to-market for medical devices, digital tools play a key role in managing converging priorities for device manufacturers.
FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...
In the document, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ...
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