The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Hardcover)

by Kimberly A. Trautman (Author) "Manufacturers establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications..." (more)
Key Phrases: device history record, design description document, design history file, American National Standard, United States, Federal Register (more...)

Product Details

• Hardcover: 210 pages
• Publisher: ASQ Quality Press (October 1996)
• Language: English
• ISBN-10: 0873893778
• ISBN-13: 978-0873893770
• Product Dimensions: 9.1 x 6 x 0.8 inches
• Shipping Weight: 1 pounds (View shipping rates and policies)
• Average Customer Review: 4.0 out of 5 stars See all reviews (2 customer reviews)
• Amazon.com Sales Rank: #493,362 in Books (See Bestsellers in Books)

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Customer Reviews

Most Helpful Customer Reviews

25 of 25 people found the following review helpful:

5.0 out of 5 stars Good at laying out the rules, December 6, 2000

By	V. Sontrop (California) - See all my reviews

Mfg. Engr. manager for a large medical device company.

After spending 2.5 days with an FDA auditor, I realized that I did not know what was expected by the regulatory body in terms of process validations, equipment installation and maintenance and all of the record-keeping and documentation that is required for them.

To learn all of that quickly, I purchased and studied this book. For each subject (process validations, equipment, calibration and all other areas), it lists the FDA regulation, the corresponding ISO regulation and then has an "FDA guidance" section that breaks down both into plainer English. It was helpful to have all of the information in one place.

The frustrating part with the FDA is that they won't tell you exactly how to do things, they'll just lay out the rules and you have to figure out how to get there from here. This book is good at laying out all of the rules.

I would recommend this book to any level person who may have to answer to an auditor. There are sections on Design Control, Nonconforming Production, Labeling and Packaging, Statistical Techniques and more that apply to each area of the business.

12 of 12 people found the following review helpful:

3.0 out of 5 stars Summarizes FDA rules, but does not discuss them, October 9, 2003

By	Murphy Pickard "eclectic reader" (Denver, CO) - See all my reviews (REAL NAME)

I bought the book based on only one review, but was a bit disappointed. It did indeed list all relevant code, and referenced it for further study, but the codes themselves are hardly self-explanatory. Except for some introductory comments, there was very little in the way of further explanation on the topics in this book.

I was looking for some interpretation, examples, what is typically done in the real world to meet requirements, etc.

It's a good reference book, but just a starting point in understanding what is necessary to satisfy the FDA in medical device manufacturing. Buy it used if possible, you won't be using it much except for reference.