The EU AI Act and the MDR are fundamentally changing the regulatory requirements for MedTech manufacturers. Today, artificial intelligence must be powerful, verifiably safe, validated and regulatory compliant.
This white paper shows in a practical way how AI systems can be integrated into medical devices in a technically sound manner, classified correctly from a regulatory perspective and brought to approval in a statistically robust manner. It covers the key topics from a reliable database to the validation of AI and post-market surveillance. The guide is aimed at anyone who develops, evaluates or uses AI in the context of an approvable medical device.
