Webinar - Fusion of AI and Medical Devices

AI is revolutionizing Medical Device Software (MDSW), but evolving regulations create uncertainty for manufacturers seeking CE-marking. In this expert-led webinar, Key2Compliance and BSI Notified Body break down the AI Act, MDR, and key regulatory challenges, offering practical guidance on how to ensure compliance and streamline approvals.

Key topics include:

• How AI-based MDSW differs from traditional software in regulatory reviews

• The biggest challenges Notified Bodies face in assessing AI medical devices

• Strategies to engage Notified Bodies early and avoid approval delays

• Why AI transparency & explainability are critical for regulatory success

Watch the recording now to stay ahead of AI compliance challenges!