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AI as a Medical Device

MDR and AI Act: dual regulation for medical AI systems

Advanced📖 6 lessons⏱️ ~25 min
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Lessons

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Lesson 2Theory

MDR classification for medical AI

The four MDR risk classes and their implications for AI

+15 XP
~4 min
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Lesson 3Case study

Case study: medical AI in practice

Three real-world scenarios for medical AI systems

+15 XP
~4 min
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Lesson 4Quiz

Quiz: medical AI regulation

Test your knowledge of MDR and AI Act for healthcare

+15 XP
~3 min
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Lesson 5Theory

IGJ, patient data & practical compliance

Supervision, GDPR overlap, and steps for healthcare organizations

+15 XP
~4 min
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Lesson 6Exam

Module Z1 exam

Test your knowledge of medical AI regulation

+50 XP
~5 min