Software in Medical Devices, by MD101 Consulting

We continue this series of articles on Artificial Intelligence with the Data Management Process.
This process is required by article 10 of the AI Act, but also from a MDR viewpoint to document the process feeding the AI design process (seen in the previous article part 2) with the right data.

The FDA published early January 2025, a long-awaited guidance about Artificial Intelligence Enabled device software functions. This guidance contains FDA's recommendations on how to document an AI-enabled device in marketing submissions.
Almost 70 pages long, this guidance is a monster!