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 ...
The FDA recently had a meeting to explore regulatory aspects of AI-enabled mental health medical devices. I explore a useful ...
Objective Medical devices account for approximately 6–10% of national health systems’ carbon footprints. The global use of single-use devices has increased, with implications for health systems’ ...
CyberActa medical device software design and development expertise minimizes vulnerabilities and reduces attack surface of every phase of the development cycle ...
FORT DETRICK, Md. -- Sustainment experts at U.S. Army Medical Logistics Command have developed new maintenance handbooks aimed at improving resource management practices and overall readiness for ...
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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