Navigating EU AI Act: Transforming Compliance for AI/SaMD Products

Navigating EU AI Act: Transforming Compliance for AI/SaMD Products

The EU AI Act is the most comprehensive regulatory frameworks for Artificial Intelligence — impacting medical devices, SaMD, predictive diagnostics, decision-support tools, remote monitoring solutions, and more.

Manufacturers operating in or entering the EU market must now align with new classification rules, conformity pathways, documentation demands, and post-market obligations.

This webinar is designed to help MedTech innovators, regulatory teams, quality professionals, and digital health developers understand how the EU AI Act will shape the lifecycle of AI-based medical technologies.

What you will learn:

✔ How the EU AI Act applies to Medical Devices & SaMD
✔ Definitions of AI systems under EU law
✔ Risk classifications & what makes a system “High-Risk”
✔ Conformity assessment routes for AI-driven medical devices
✔ Required documentation, technical files, QMS expectations & transparency obligations
✔ Post-market monitoring, cybersecurity, and human oversight requirements
✔ Practical steps to prepare your organization for compliance

Event Details

📅 13 November 2025
⏰ Starts 15:00 CET | 09:00 EST | 20:00 IST
📍Teams Live Online Webinar
✅ Free Registration

Whether you are developing decision-support algorithms, diagnostic software, remote monitoring tools, or predictive analytics — this session will give you clarity and actionable steps to stay compliant and competitive.

👉 Register Now - https://events.teams.microsoft.com/event/2de46668-30b9-45a2-a423-086528769fa5@a819dd7e-a66d-4a32-9c6e-65a106564e2c

🌐 www.reg-trac.com | 📩 info@reg-trac.com
We look forward to having you attend the event!