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Medical Device Quality Assurance and Regulatory Compliance [Hardcover]

Richard C. Fries (Author)

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

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Book Description

Publication Date: August 1, 1998 | ISBN-10: 0824701771 | ISBN-13: 978-0824701772 | Edition: 1

"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

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Product Details

Hardcover: 496 pages
Publisher: CRC Press; 1 edition (August 1, 1998)
Language: English
ISBN-10: 0824701771
ISBN-13: 978-0824701772
Product Dimensions: 9 x 6.3 x 1.1 inches
Shipping Weight: 1.8 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: #2,499,081 in Books (See Top 100 in Books)

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More About the Author

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2.0 out of 5 stars Overpriced and underwelmed, May 13, 2011

Alan Fryer "frydaz.com" (Portland) - See all my reviews
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This review is from: Medical Device Quality Assurance and Regulatory Compliance (Kindle Edition)

Typically I like succinct books but I see little value in this book considering it's price. Just too brief in it's overviews.

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Inside This Book (learn more)

First Sentence:
As a result of revolutionary changes that have occurred around the world, we are part of an inevitable phenomenon: globalization of the economy. Read the first page

Key Phrases - Statistically Improbable Phrases (SIPs): (learn more)
risk management file, programmable electronic medical system, effectiveness for the individual company, risk management summary, active medical device, quality system regulation, medical electrical equipment, purchased product conforms, performing specific assigned tasks, notified body, collateral standard, sterile medical devices, design history file, quality audit reports, significant environmental aspects, active implantable, design input requirements, predicate device, medical device reporting, nonconforming product, notified bodies, implantable medical devices, environmental management system, conformity assessment procedure, purchasing documents

Key Phrases - Capitalized Phrases (CAPs): (learn more)
United States, Requirements All, New York, Marcel Dekker, Cosmetic Act, Federal Food, International Electrotechnical Commission, Requirements Clause, Compliance Compliance, European Commission, European Community, Competitive Environment, Environmental Protection Agency, European Union, Federal Register, Global Harmonization Task Force, Requirements Each, Device Master Record, All All, Procedures Documented, Environmental Management Systems, European Free Trade Association, Government Printing Office, Quality Press, Study Group

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Books on Related Topics | Concordance | Text Stats

Citations (learn more)

This book cites 13 books:

Reliable Design of Medical Devices, Second Edition by Richard C. Fries on 12 pages
Global Paradox by John Naisbitt on page 11
The Medical Device Industry by Norman F. Estrin on page 11
Health and Safety (Statutory Instruments) by The Stationery Office on page 76
Interventional Radiology by Renan Uflacker on page 26

See all 13 books this book cites

6 books cite this book:

Medical Device Reliability and Associated Areas by B.S. Dhillon on page 137, and Back Matter
Human Reliability and Error in Medical System (Industrial and Systems Engineering, 2) by B. S. Dhillon on page 10
Safety Evaluation of Medical Devices, Second Edition, by Shayne C. Gad on page 52
Design of Biomedical Devices and Systems by Richard C. Fries on page 421
Handbook of Medical Device Design by Richard C. Fries on page 73

See all 6 books citing this book

Books on Related Topics (learn more)

The ISO 9000 Handbook Fourth Edition by Robert Peach

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The Medical Device Industry by Norman F. Estrin

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Design of Biomedical Devices and Systems by Paul H. King

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Validation for Medical Device and Diagnostic Manufacturers, Second Edition by Carol DeSain

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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition by Amiram Daniel and Edward Kimmelman Hardcover
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Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices by Elaine Whitmore Paperback
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