Latest / Medical Device made Easy Podcast
Best of „AI CE marking“
Artificial intelligence is transforming healthcare, but developing an AI medical device is only part of the challenge. Manufacturers must also navigate certification requirements and maintain safety and performance throughout the entire product lifecycle.
In two podcast episodes featuring Sandy Wright and Osman El-Koubani, we explore the journey from certifying LLM-driven medical devices to managing them after CE marking.
Certifying LLM-Driven Medical Devices
Large Language Models such as ChatGPT, Gemini, and Claude introduce new regulatory challenges. Unlike traditional software, these…
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