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Reliable Design of Medical Devices 2nd Edition by Richard Fries 0824723759 978-0824723750

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Reliable Design of Medical Devices 2nd Edition Richard C. Fries Digital Instant Download

Author(s): Richard C. Fries
ISBN(s): 9781420027945, 1420027948
Edition: 2
File Details: PDF, 10.35 MB
Year: 2005
Language: english
SKU: EB-1133592 Category: Tag:

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Product details:

ISBN 10: 0824723759

ISBN 13: 978-0824723750

Author: Richard C. Fries

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.

Table of contents:

Section 1 Basics of reliability
Chapter 1: Reliability
Chapter 2: The concept of failure

Section 2 Regulations and standards
Chapter 3: The Food and Drug Administration
Chapter 4: The Medical Devices Directives
Chapter 5: Quality system regulation
Chapter 6: Domestic standards
Chapter 7: International standards

Section 3 Specifying the product
Chapter 8: The medical device as an entity
Chapter 9: Defining the device
Chapter 10
Chapter 11
Chapter 12: Liability
Chapter 13

Section 4 Designing the product
Chapter 14: Six Sigma and product design
Chapter 15: Hardware design
Chapter 16: Software design
Chapter 17: Software coding
Chapter 18: Establishing and using metrics
Chapter 19: Human factors

Section 5 Testing and data analysis
Chapter 20: The basis and types of testing
Chapter 21: Hardware verification and validation
Chapter 22: Software verification and validation
Chapter 23: Analysis of test results

Section 6 The manufacturing and maintenance processes
Chapter 24: GMPs and manufacturing
Chapter 25: Configuration management
Chapter 26: Analysis of field data

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