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Handbook of Medical Device Design (Hardcover)

~ Richard C. Fries (Author) "Regulation of medical devices is intended to protect consumer's health and safety by attempting to ensure that marketed products are effective and safe..." (more)
Key Phrases: sudden death line, software fault tree analysis, part planning matrix, New York, United States, John Wiley (more...)
2.0 out of 5 stars  See all reviews (1 customer review)
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Frequently Bought Together

Handbook of Medical Device Design + The Medical Device R&D Handbook + Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration
Price For All Three: $420.44

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Editorial Reviews

Review

"a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections."
---E-Streams

a worthwhile reference and source. . ..Biomedical and engineering libraries would benefit from this addition to their reference collections.
---E-Streams


Product Description

Datex-Ohmeda, Inc., Madison, WI. Handbook includes practical techniques which a developer and manufacturer of medical devices may incorporate in their processes to improve the methodology of designing and manufacturing medical devices, and improve the functionality and reliability as well. Layout follows a typical product development process. Outline format.

Product Details

  • Hardcover: 774 pages
  • Publisher: CRC; 1st edition (January 15, 2001)
  • Language: English
  • ISBN-10: 0824703995
  • ISBN-13: 978-0824703998
  • Product Dimensions: 9.1 x 6.1 x 1.6 inches
  • Shipping Weight: 2.5 pounds (View shipping rates and policies)
  • Average Customer Review: 2.0 out of 5 stars  See all reviews (1 customer review)
  • Amazon.com Sales Rank: #1,538,796 in Books (See Bestsellers in Books)

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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
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Inside This Book (learn more)
First Sentence:
Regulation of medical devices is intended to protect consumer's health and safety by attempting to ensure that marketed products are effective and safe. Read the first page
Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
sudden death line, software fault tree analysis, part planning matrix, manual development process, auditor actions, state conformance, backwards traceability, translation coordinator, notified body, quality system regulation, medical device software, developmental configuration, total failure rate, notified bodies, predicate device, conformity assessment procedure, premarket notification, infringing device, medical device regulations, submitting documentation, medical device industry, marketed device, trade secret owner, software requirements specification, medical device manufacturers
Key Phrases - Capitalized Phrases (CAPs): (learn more)
New York, United States, John Wiley, Marcel Dekker, Department of Defense, Medical Device Directive, Competitive Environment, European Union, Cosmetic Act, Department of Health, Englewood Cliffs, European Commission, European Community, Book Company, New Jersey, Canadian Electrical Code, Federal Food, Federal Register, Policy Document, Quality Function Deployment, Addison Wesley Longman, American National Standards Institute, Device Master Record, Government Printing Office, Major Level of Concern
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Front Cover | Table of Contents | First Pages | Index | Back Cover | Surprise Me!
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This book cites 84 books:
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What Do Customers Ultimately Buy After Viewing This Item?

Handbook of Medical Device Design
32% buy the item featured on this page:
Handbook of Medical Device Design 2.0 out of 5 stars (1)
$239.34
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The Medical Device R&D Handbook
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Design Controls for the Medical Device Industry
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18 of 18 people found the following review helpful:
2.0 out of 5 stars Insufficient detail to be of much use, May 3, 2001
The typesetting of this book makes it very difficult to read. It appears to be a scan of a typed page. In any event, although it does summarize some of the basics of medical device design such as design controls, the design file, submission of an IDE/510(k)/or PMA, it does not give enough detail to be of any use. The reader can get all of the information in this book from FDA guidance documents, which are free.
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