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 ...
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 ...
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 ...
On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and ...
Given the highly infectious nature of the COVID pathogen, tests for the virus had to be quick, reliable and safe. The test ...
VALENCIA, Calif.--(BUSINESS WIRE)--SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total ...
Symphoni platform delivers real-time in-line quality assurance for medical devices, up to 320 parts per minute with 90% less ...
The ISO 13485:2016 training course presents a key market opportunity for medical device organizations to enhance their quality management systems, ensuring compliance with industry and regulatory ...
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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