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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, 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.
