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October 29, 2025

Validating ChatGPT: What medical device manufacturers need to consider

By Prof. Dr. Christian Johner October 29, 2025 Leave a comment

Is there a duty for medical device manufacturers for validating ChatGPT and other LLMs that they use in the development, production, approval, and monitoring of their products? If so, how can this be achieved with models that deliver non-deterministic results? This technical article provides answers to these questions and to the question of what your…

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Regulatory requirements for medical devices with machine learning

By Prof. Dr. Christian Johner October 29, 2025 1 Comment

Manufacturers who use machine learning (ML) in their medical devices or IVDs must comply with numerous regulatory requirements. This article provides an overview of the most important regulations and best practices for implementation. It saves you the trouble of researching and reading hundreds of pages and helps you prepare perfectly for your next audit.

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