This course covers the critical issues relating to the risk management and implementation of new technologies in the healthcare sector. It represents a comprehensive summary of the advances in clinical engineering and presents guidance on compliance and safety for hospitals and engineering teams. Students will solve common problems in the area of healthcare technology. Topics include compliance with the European Directive on Medical Devices 93/42/EEC, European Norms EN 60601-1-6, EN 62366, and the American Standards ANSI/AAMI HE75: 2009. Content coverage includes decision support systems, clinical complex systems, and human factor engineering. Examples are fully supported with case studies, and global perspective is maintained throughout. The course emphasizes how to assess new healthcare technologies and what are the most critical issues in their management, and provides information on how to carry out risk analysis for new technological systems or medical software. Various tactics on how to improve the quality and usability of medical devices will be explored .