In 2024, the FDA approved over a hundred AI-enabled medical devices, highlighting rapid innovation in healthcare technology. The FDA also introduced fresh draft guidelines emphasizing continuous validation, lifecycle management, and tighter cybersecurity protocols. Discover how these medical device design standards impact device manufacturers and what steps must be taken now to ensure compliance and patient safety. 

Read more: https://vantagemedtech.com/medical-device-design-standards-for-AI-enabled-devices

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