Ebook Free The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
Ebook Free The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition
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Product details
Hardcover: 336 pages
Publisher: ASQ Quality Press; 2 edition (June 6, 2008)
Language: English
ISBN-10: 0873897404
ISBN-13: 978-0873897402
Product Dimensions:
6.2 x 1 x 9.2 inches
Shipping Weight: 1.4 pounds (View shipping rates and policies)
Average Customer Review:
3.9 out of 5 stars
4 customer reviews
Amazon Best Sellers Rank:
#766,954 in Books (See Top 100 in Books)
This is a handy guidebook for any FDA related information on medical devices. This book was an easy read along with the information being easy to understand. This was a syllabus requirement for my class and it was easy to find on Amazon and cheaper to purchase here. All guidebooks should follow the format that these authors used to create it.
Steep price tag but worth it because - This is a good basic reference book for 21 CFR 820. It provides an outline of each requirement of the QSR with cross reference to and comparison with ISO 13485. It contains a matrix of 820 vs. 13485 with authors' notes that describe similarities/differences. It provides reference to the guidance ISO/TR 14969 which clarifies 13485. It also contains a section on process interactions, i.e., how CAPA interacts with Risk Analysis, etc. There is a chapter on Risk Analysis and information on Design Control. The comments to the QSR preamble are included and elaborated on which is helpful in determining the intent of law, useful for interpretation and application of the QSR . The authors offer useful guidance and some interpretation. All in all a good reference for new and/or practicing Quality Assurance staff, device managers, those seeking ISO medical device certification or improving their compliance in preparation for audits.
Excellent, Thanks
The book was a very handy guide to help put FDA and ISO requirements for medical devices in perspective, in its day. However, this edition is based on obsolete versions of FDA21CFR Part 820, ISO14969 and ISO13485. Use of this book now could get you in trouble!!
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