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Friday, 24 July 2026
By Mitch on Friday, 24 July 2026, 12:44 - Regulations
While lot's of people wait for the 2nd version of IEC 62034, lots of other standards are being published or in the works. A few years back, IEC 62304 was alone on the scene. Then came IEC 82304-1. Now, it's raining standards. IEC 62304 2nd edition may not be the new kid on the block.
Friday, 24 April 2026
By Mitch on Friday, 24 April 2026, 15:58 - Standards
IEC PAS 63621 2026 - Artificial intelligence enabled medical devices - Data management, has been published in March 2026.
A PAS is a Publicly Available Specification, a kind of early version of a standard. It was developed by IEC at a pace quicker than usual. Too quick to follow the long process of standard development.
Friday, 6 March 2026
By Mitch on Friday, 6 March 2026, 13:32 - Templates
After talking about AI in a series of articles, and especially about the data management process, we introduce two new templates: the Data Management Plan and Data Management Report.
Friday, 17 October 2025
By Mitch on Friday, 17 October 2025, 14:03 - Processes
We continue this series of articles on Artificial Intelligence with the Risk Management Process.
Simply put, risk management for MDAI isn't dramatically different from risk management for classical MDSW. Yet, some interesting points of view can be found in literature and standards. Namely AAMI TIR 34971 and FDA guidances on AI. The future ISO TS 24971-2 on risks with AI should be published in 2026.
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.
