FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
Artificial intelligence medical devices are changing how we do healthcare. It’s a big shift, and like anything ...
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 ...
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 ...
Language Scientific has provided a practical overview of IFU translation requirements for medical device documentation, emphasizing how clear and accurate Instructions for Use support patient safety, ...
Draft guidelines aim to align India's medtech software framework with global practices; industry seeks more clarity on AI/ML ...
Emerging medical technologies are testing how law regulates ownership, data and responsibility when devices become part of the person.
Artificial intelligence (AI) is no longer the future of healthcare—it’s already here. AI-driven medical devices are diagnosing diseases faster than doctors, guiding surgical procedures with precision ...
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