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Handbook of Medical Device Design [Hardcover]

Richard C. Fries (Author)

2.0 out of 5 stars See all reviews (1 customer review) |

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Book Description

ISBN-10: 0824703995 | ISBN-13: 978-0824703998 | Publication Date: January 15, 2001 | Edition: 1st

The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include

#outer_postBodyPS { display: none; } #psGradient { display: none; } #psPlaceHolder { display: none; } #psExpand { display: none; } The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include

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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

Product Details

Hardcover: 774 pages
Publisher: CRC Press; 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 Best Sellers Rank: #1,171,133 in Books (See Top 100 in Books)

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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

Jeffrey C. Stephens "Jeff" (Athens, GA USA) - See all my reviews
(REAL NAME)

This review is from: Handbook of Medical Device Design (Hardcover)

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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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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Books on Related Topics | Concordance | Text Stats

Citations (learn more)

This book cites 84 books:

Reliable Design of Medical Devices, Second Edition by Richard C. Fries on 9 pages
Reliability Assurance for Medical Devices, Equipment and Software by Richard C. Fries on 5 pages
Software Engineering: A Practitioner's Approach by Roger Pressman on 4 pages
Interventional Radiology by Renan Uflacker on page 19, and page 47
Software Engineering Concepts (Mcgraw-Hill Series in Software Engineering and Technology) by Richard E. Fairley on page 351, and page 626

See all 84 books this book cites

2 books cite this book:

Six Sigma for Medical Device Design by Jose Justiniano in Back Matter
Design of Biomedical Devices and Systems by Richard C. Fries on page 421

Books on Related Topics (learn more)

FDA Regulatory Affairs by Douglas J. Pisano

Discusses:

The Medical Device Industry by Norman F. Estrin

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The Medical Device R&D Handbook, Second Edition by Theodore R. Kucklick

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Design of Biomedical Devices and Systems by Paul H. King

Discusses:

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