The EU AI Act is here β the worldβs 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 β including real-time biometric surveillance. If your medical device or software uses AI, you must understand your obligations and act early.
π Join SoftComply this Thursday for an exclusive webinar on "Navigating Audits, the AI Act & the Medical Device Regulation" featuring expert insights β including from Notified Body BSI β as we explore what this means for your organisation and how to stay ahead.
ποΈ Date: May 22, 2025
π Time: 04:00 PM CET
π Live Online | Free Registration
In this session, you'll learn:
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Key milestones for CE Conformity Assessment
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How to implement an effective eQMS
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Real-world audit scenarios and how to prepare for audits
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How the AI Act intersects with MDR β and what it means for your medical device software
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Live Q&A β 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 β and make sure your compliance strategy is future-proof!
π Register here -> https://us02web.zoom.us/webinar/register/WN_0o5VG2RNQKepjkAxFTrG_w
Marion Lepmets _SoftComply_
CEO
SoftComply
Munich, Dublin, Tallinn
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