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 a practical and comprehensive overview of product safety risk management and performance testing for medical and in vitro diagnostic devices. Students will learn how to identify, evaluate, and mitigate risks across the entire device lifecycle using international frameworks such as ISO 14971, ISO 13485, and FDA QMSR. The course combines theory with real-world examples, focusing on design assurance, hazard analysis, usability, and post-market monitoring to ensure the safety and performance of medical technologies.