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Friday, 29 August 2025
By Mitch on Friday, 29 August 2025, 13:47 - Processes
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.
Thursday, 14 August 2025
By Mitch on Thursday, 14 August 2025, 13:29 - Regulations
The TÜV AI.Lab published two white papers on the interaction between the AI Act and the MDR:
Better Safe Than Sorry? ISO 13485 and the EU AI Act
and:
AI Act and MDR - A match made in heaven or double the trouble.
Some serious content behind the itching titles.
Friday, 7 February 2025
By Mitch on Friday, 7 February 2025, 13:53 - Regulations
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!
Thursday, 6 February 2025
By Mitch on Thursday, 6 February 2025, 14:47 - Misc
For those who've followed this blog for a long time, nothing relevant has been published on artificial intelligence / Machine Learning yet. Just a few words on artificial intelligence appear in the essential list of guidances, to refer to existing FDA guidance.
