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 needsExplains how to assess new healthcare technologies and what are the most critical issues in their managementProvides information on how to carry out risk analysis for new technological systems or medical softwareContains tactics on how to improve the quality and usability of medical devices