Although Reliability Engineering can trace its roots back to World War II, its application to medical devices is relatively recent, and its treatment in the published literature has been quite limited. With the medical device industry among the fastest growing segments of the US economy, it is vital that the engineering, biomedical, manufacturing, and design communities have up-to-date information on current developments, tools, and techniques.
Medical Device Reliability and Associated Areas fills this need with broad yet detailed coverage of the field. It addresses a variety of topics related - directly and indirectly - to reliability, including human error in health care systems and software quality assurance. With emphasis on concepts rather than mathematical rigor, a multitude of examples, exercises, tables, and references, this is one resource that everyone connected to the medical device industry must have.
Introduction. Basic Reliability Mathematics and Concepts for Medical Devices. Tools for Medical Device Reliability Assurance. Human Error in Health Care Systems. Medical Device Software Quality Assurance and Reliability. Medical Device Safety Assurance .Medical Device Risk Assessment and Control. Medical Device Quality Assurance. Medical Device Reliability Testing. Medical Device Costing. Medical Device Maintenance and Maintainability. Reliability Related Standards, Failure Data Sources, and Failure Data and Analysis for Medical Devices.