Built for the EU AI Act: a QMS ready for AI-enabled medical devices
AI is moving into medical devices faster than most quality systems can follow. MoniDoseQMS provides a dedicated module suite for EU AI Act compliance.
By MoniDoseQMS Team
Artificial intelligence is reshaping diagnostics, imaging, and decision support — and regulation is catching up. The EU AI Act introduces obligations for high-risk AI systems, and many AI-enabled medical devices fall squarely into that category, on top of their existing MDR and IVDR duties. Most quality systems were never designed for this. We built for it deliberately.
A dedicated AI Act module suite
- AI system inventory and AI system registrations
- AI risk assessment and conformity assessment
- AI data governance and technical documentation
- Human oversight and transparency records
- AI post-market monitoring and incident reporting
- Fundamental rights assessment
Why this is different
The AI Act does not replace medical device regulation — it layers on top of it. The strength of handling both in one platform is that AI risk, data governance, and post-market monitoring stay connected to the device's design controls, ISO 14971 risk file, and clinical evidence. You manage one coherent system, not two that have to be reconciled.
AI-enabled devices carry two sets of obligations. They should not need two disconnected quality systems to meet them.