Latest / Medical Device made Easy Podcast
Can You Certify an LLM-Driven Medical Device?
Large Language Models (LLMs) such as ChatGPT, Gemini, and Claude are rapidly transforming digital healthcare.
From clinical decision support to medical documentation and patient interaction, generative AI is opening new possibilities for Software as a Medical Device (SaMD).
But one major question remains:
Can an LLM-driven medical device actually be certified?
What Is an LLM-Driven Medical Device?
An LLM-driven medical device uses generative AI technology to perform functions that may influence clinical decisions, patient management, or healthcare workflows.
Unlike traditional rule-based…
The skinny
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