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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.
