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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, 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, 16 May 2025
By Mitch on Friday, 16 May 2025, 13:53 - Regulations
The Team-NB published the V2 of a position paper on the EU AI Act in April 2025.
It's interesting to see that this paper was published just before the white paper from BSI.
By Mitch on Friday, 16 May 2025, 13:51 - Regulations
BSI Notified Body published in May 2025 a new White Paper on the AI Act and its interactions with MDR / IVDR.
