Reliable Design of Medical Devices. Questo articolo non è disponibile.Reliable Design of Medical Devices

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.

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