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212 - Guest: Antonina Burlachenko, AI Regulatory Consultant

Artificial Intelligence and You

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Implications of European AI Act on Medical Device Regulation

Discussion on how the European AI Act classifies AI systems, particularly high-risk AI systems, impacting medical devices already governed by regulations like MDR and IVDR. Exploration of the intersection between existing regulations and the new AI Act, including the challenges faced by providers of high-risk AI systems and medical devices in meeting the requirements.

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