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 ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, ...

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 ...

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 ...