Fries, Richard C.
2nd ed. - Boca Raton : CRC/Taylor & Francis, 2006.
- xxvi, 475 p. : ill. ; 25 cm.
Includes bibliographical references and index.
- BASICS OF RELIABILITY Reliability The Concept of Failure REGULATIONS AND STANDARDS The Food and Drug Administration The Medical Device Directives Quality System Regulation Domestic Standards International Standards SPECIFYING THE PRODUCT The Medical Device as an Entity Defining the Device Requirements Engineering Safety and Risk Management Liability Intellectual Property DESIGNING THE PRODUCT Six Sigma and Product Design Hardware Design Software Design Software Coding Establishing and Using Metrics Human Factors TESTING AND DATA ANALYSIS The Basis and Types of Testing Hardware Verification and Validation Software Verification and Validation Analysis of Test Results THE MANUFACTURING AND MAINTENANCE PROCESSES GMPs and Manufacturing Configuration Management Analysis of Field Data APPENDICES Appendix 1: Chi Square Table Appendix 2: Percent Rank Tables Appendix 3: Common Failure Modes Appendix 4: Glossary INDEX.
- (source: Nielsen Book Data)
- Publisher's Summary:
As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, "Reliable Design of Medical Devices" illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, "Reliable Design of Medical Devices, Second Edition" leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.
(source: Nielsen Book Data)