Guide to AI in medical devices: Integrate safely, approve validly

With the EU AI Act and the MDR, MedTech manufacturers are facing a new regulatory reality: Artificial intelligence must not only be powerful, but also demonstrably safe, validated and compliant.

This white paper shows in a practical way how AI systems in medical devices can be integrated in an architecturally clean way, classified correctly from a regulatory perspective and approved with statistical validity. From data governance to AI validation and post-market surveillance. A guide for anyone who thinks of AI not as an experiment, but as an approved medical device.