Cybersecurity for medical devices has become a critical concern in the healthcare industry as these devices become increasingly connected and sophisticated. This three-day seminar focuses on the dynamic cybersecurity landscape within the medical device industry including standards and regulatory compliance.

The curriculum covers the fundamental principles of IEC 62304, the international standard for medical device software. Participants will gain insights into quality management systems, risk management, software safety classification, verification and validation, and cybersecurity testing. The course also examines cybersecurity concerns through the lens of IEC 62443 and explores the integration of Security by Design using risk management principles from ISO 14971 and Threat Analysis and Risk Assessment (TARA). This comprehensive approach aims to help participants prioritize product design, development, and testing to meet critical security requirements within the broader design framework.