WELCOME TO ALEPH.

This course provides a comprehensive understanding of safety risk management principles as applied to the medical technology (MedTech) sector. Based on ISO 14971:2019 and ISO/TR 24971, it trains students to identify, assess, control, and monitor risks associated with medical devices throughout their lifecycle. The course emphasizes the integration of risk management within regulatory frameworks, usability engineering, and quality systems. Through case studies and applied analysis, students will learn to evaluate device safety, design compliant documentation, and ensure regulatory alignment across the MedTech industry.

This course provides an in-depth examination of the global regulatory frameworks that govern medical devices. Students will explore the U.S. FDA and European Union MDR/IVDR systems while analyzing the evolving challenges brought by artificial intelligence, digital health, and emerging technologies. Through case studies, readings, and policy analysis, students learn to navigate regulatory requirements, evaluate the impact of legislation on innovation, and assess ethical and legal implications within the international healthcare landscape.

This course introduces students to innovative biomedical instrumentation technologies with a strong focus on real-world applications in healthcare. Through current case studies, students explore the development, design, and evaluation of medical devices addressing the needs of people with disabilities and chronic conditions. The course integrates engineering, regulatory, and quality assurance principles, encouraging interdisciplinary collaboration to create safe, effective, and compliant biomedical solutions that improve patient care and quality of life.

This course provides a comprehensive introduction to the fundamental principles of medical physics and their application to diagnostic and therapeutic technologies in modern healthcare. Students will explore the physics of radiation, dosimetry, and imaging systems such as X-ray, CT, MRI, ultrasound, and nuclear medicine. The course also covers radiation therapy techniques, radiation protection, quality assurance, and emerging technologies including AI, photoacoustic imaging, and FLASH radiotherapy. Through readings, assignments, and discussions, students will connect theoretical physics with clinical applications and regulatory frameworks (FDA, IEC, ISO).