Units

1. Introduction to Artificial Intelligence and Verification Discipline in Biomedical Engineering 2. Medical Image Analysis Support: Radiology (X-ray, CT, MR) 3. Digital Pathology and Tissue Image Analysis 4. Biosignal Processing: ECG and Cardiac Signals 5. Biosignal Processing: EEG and Neurological Signals 6. Wearable Sensors and Continuous Physiological Monitoring 7. Clinical Data Analysis and Electronic Health Records 8. Medical Device Design and Device Software (SaMD) 9. Regulatory Research and Verification: CE/FDA, MDR 10. Ethics, Patient Privacy and Data Governance (KVKK/HIPAA) 11. End-to-End Integration, Boundaries and Responsible Execution

Unit 9 / 11

Regulatory Research and Verification: CE/FDA, MDR

Gains:

Ability to explain research and draft support of artificial intelligence within the framework of CE marking, FDA pathways and Medical Device Regulation (MDR)
Understand that regulatory text outputs carry the risk of fabricated citations and false articles and how to verify them.
Ability to determine where AI ends for clinical evaluation, verification/validation (V&V) and technical dossier

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