Clinical Systems Engineering: New Challenges for Future Healthcare covers the critical issues relating to the risk management and design of new technologies in the healthcare sector. It is a comprehensive summary of the advances in clinical engineering over the past 40 years, presenting guidance on compliance and safety for hospitals and engineering teams.

This contributed book contains chapters from international experts, who provide their solutions, experiences, and the successful methodologies they have applied to 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. This book is ideal for clinical engineers, biomedical engineers, hospital administrators and medical technology manufacturers.

• Presents clinical systems engineering in a way that will help users answer many questions relating to clinical systems engineering and its relationship to future healthcare needs
• Explains how to assess new healthcare technologies and what are the most critical issues in their management
• Provides information on how to carry out risk analysis for new technological systems or medical software
• Contains tactics on how to improve the quality and usability of medical devices