AI-Enabled Medical Devices: From Innovation to Compliance

Artificial intelligence is transforming healthcare — from diagnostic imaging and clinical decision support to predictive analytics and personalized treatment. At the same time, regulatory frameworks are rapidly evolving to ensure that these technologies are safe, reliable, and trustworthy. 

With the introduction of the EU Artificial Intelligence Act (AI Act) alongside the existing EU Medical Device Regulation (MDR), manufacturers, regulators, and notified bodies face a new challenge: how to translate innovation into compliant medical products. 

This webinar explores how AI-enabled medical devices move from technological innovation to regulatory acceptance, focusing on risk management, clinical evidence, and post-market monitoring.

Key Questions Addressed

• Is regulation slowing down innovation in AI-enabled medical devices?
• How does the AI Act change risk management for medical devices?
• How should clinical evaluation strategies be adapted for AI systems?
• What does meaningful Post-Market Clinical Follow-Up (PMCF) look like for AI-enabled devices?

Who Should Attend

• Medical device manufacturers developing AI-based products
• Regulatory affairs and quality professionals
• Clinical evaluation specialists
• Notified body auditors and technical documentation assessors

What You Will Learn

Participants will gain practical insight into:

• The regulatory landscape for AI-enabled medical devices
• Integrating risk management and clinical evidence strategies
• Designing clinical evaluation approaches suitable for AI systems
• Implementing effective post-market monitoring for AI performance