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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.
- Sales Rank: #3039876 in Books
- Brand: Brand: CRC Press
- Published on: 2005-11-21
- Original language: English
- Number of items: 1
- Dimensions: 1.27" h x 6.44" w x 9.24" l, 1.86 pounds
- Binding: Hardcover
- 504 pages
- Used Book in Good Condition
Review
"This book is an absolute must for anybody who is just overwhelmed by the prospect of having to go through the various standards that are becoming increasingly important to manufacturers and users alike. . ..It not only explains every aspect of the science of reliable design but provides clear definitions of the jargon and good practical examples of the paperwork required from the various certifying bodies. . . .it is unlikely that most of us will ever need to refer to any other book than this one." ---Proceedings of the Institution of Mechanical Engineers
About the Author
Fries; Richard Baxter Healthcare, Round Lake, Illinois, USA,
Most helpful customer reviews
6 of 6 people found the following review helpful.
Excellent reference
By Zentao
This book provides a solid reference for the Systems Engineer who is working on a medical device, including for IVD devices. The book is specifically structured to cover the design process and important documentation requirements in order to meet FDA 510(k) submissions. It also introduces the more typical reliability design process approach used in other industries such as telecommunications, to the design of medical devices.
The chapters of the book develop many areas of the engineering design process specific to biotechnology. The book covers the important area of 14971 Risk Assessment requirements and how this standard impacts the engineering design process. The book provides good ideas for incorporating 14971 into the standard engineering design process.
The book is useful for both medical devices (60601 requirements) as well as providing guidance for IVD devices. It lists many references for the medical systems engineer. I highly recommend it as a reference book.
0 of 0 people found the following review helpful.
My knowledge was beyond the book so my review may not reflect the average reader.
By Mr Mike
Worked Reliability for Lockheed Martin for many years. Did not teach me anything I didn't already know. However, I was a Corporate Fellow when I retired so I was pretty knowledgeable.
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