🎙️ Webinar Invite on Navigating Audits: Expert Insights from a Notified Body on the AI Act and MDR

Marion Lepmets _SoftComply_

The EU AI Act is here – the world’s first major AI regulation, reshaping how companies build and use intelligent systems. For medical device software, this means tighter rules, higher expectations, and a major shift in how they approach compliance.

The AI Act categorises systems by risk and bans certain practices – including real-time biometric surveillance. If your medical device or software uses AI, you must understand your obligations and act early.

👋 Join SoftComply this Thursday for an exclusive webinar on "Navigating Audits, the AI Act & the Medical Device Regulation" featuring expert insights – including from Notified Body BSI – as we explore what this means for your organisation and how to stay ahead.

🗓️ Date: May 22, 2025
🕓 Time: 04:00 PM CET
📍 Live Online | Free Registration

In this session, you'll learn:
✅ Key milestones for CE Conformity Assessment
✅ How to implement an effective eQMS
✅ Real-world audit scenarios and how to prepare for audits
✅ How the AI Act intersects with MDR – and what it means for your medical device software
✅ Live Q&A – Your chance to ask the experts directly

Whether you're in regulatory, quality or development, this webinar gives you a practical roadmap to align with the fast-evolving EU regulatory landscape.

Secure your spot now – and make sure your compliance strategy is future-proof!

👉 Register here -> https://us02web.zoom.us/webinar/register/WN_0o5VG2RNQKepjkAxFTrG_w