Compliance9 April 20265 min read
Module spotlight: the EU AI Act module suite
AI-enabled devices carry a second layer of obligation. A closer look at the dedicated AI Act modules that keep that obligation manageable and connected.
By MoniDoseQMS Team
We have written about why we built for the EU AI Act. Here is a closer look at the modules themselves — a dedicated suite that addresses the AI Act's obligations for high-risk AI systems, kept connected to the device's existing design, risk, and post-market files.
What the suite covers
- AI system inventory and AI system registrations
- AI risk assessment and AI conformity assessment
- AI data governance and AI technical documentation
- AI human oversight and AI transparency records
- AI post-market monitoring and AI incident reporting
- AI fundamental rights assessment and AI quality management
Why it matters
The EU AI Act layers on top of medical device regulation rather than replacing it. Handling both in one platform means AI risk, data governance, and monitoring stay connected to the device's ISO 14971 risk file, design controls, and clinical evidence — one coherent system instead of two.