| View Larger Image | Reliable Design of Medical Devices, Second Edition | Hardcoverby Richard C. Fries (Author)
| List Price: | $164.95 | | Price: | $141.44 | | You Save: | $23.51 (14%) | | | Available: | Usually ships in 24 hours |
| | Binding: | Hardcover | | Publisher: | CRC | | Edition: | 2nd Edition | | Page Count: | 504 Pages | | Publication Date: | November 21, 2005 | | Sales Rank: | 633,401rd |
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ACCESSORIES |
| Six Sigma for Medical Device Design
by Jose Justiniano (Author), Smita Gopalaswamy (Author)
For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do the same for the medical devices field.
Six Sigma for Medical Device Design is the first book to approach the subject for use in the medical...
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| The Medical Device R&D Handbook
by Theodore R. Kucklick (Editor)
The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that...
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| Designing Usability Into Medical Products
by Michael E. Wiklund (Author), Stephen B. Wilcox (Author)
Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range of alternative approaches to the subject. Wiklund and Wilcox explore how to make medical devices safe and effective by involving users in the design...
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EDITORIAL REVIEWS |
Product Description
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. |
CUSTOMER REVIEWS (Average Customer Rating: 5.0 based on 1 review)
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Excellent reference by Yuri Kuzyk (Toronto, Ontario Canada)  5 Stars
April 24, 2009
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.
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SIMILAR PRODUCTS |
| The Medical Device R&D Handbook
by Theodore R. Kucklick (Editor)
The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that...
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| Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration
by Gordon Harnack (Author)
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| The FMEA Pocket Handbook
by Kenneth W. Dailey (Author)
Speak the Language - Understand the Concepts - Know the Techniques "The FMEA Pocket Handbook" is intended as a reference guide covering the terms, concepts and techniques involved in the FMEA system. It is written in an easy to understand fashion making it useful to both the seasoned Professional and the Novice. Paper Back - .166" x 3 ¾" x 5 ½" - 40 Pages - 30 Visuals - 6 Tables - 33 Definitions
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| Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
by Elaine Whitmore (Author)
There have been revolutionary changes to the classification and regulation of prescription drugs, biologics, and medical devices since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regulated by the FDA. The revised book includes: a review of the significant changes within the FDA that affect the requirements and review of medical products; updated facts and figures; expansion of subjects that have grown more...
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| The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
by Kimberly A. Trautman (Author)
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