Free eBooks Validation For Medical Device And Diagnostic Manufacturers, Second Edition Available To Downloads
Implementation of FDA's Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation studies must be performed before or as a product is transferred to commercial production. Validation studies must demonstrate that product design, process, and test methods/requirements/specifications determined during development can be met in the environment of intended use. This book provides practical guidance on how to develop and validate product designs, manufacturing processes, and test methods that comply with the requirements of QSR.
Hardcover: 336 pages
Publisher: CRC Press; 2 edition (September 30, 1997)
Language: English
ISBN-10: 1574910639
ISBN-13: 978-1574910636
Product Dimensions: 6 x 0.9 x 9.4 inches
Shipping Weight: 1.2 pounds (View shipping rates and policies)
Average Customer Review: 4.0 out of 5 stars See all reviews (2 customer reviews)
Best Sellers Rank: #1,451,489 in Books (See Top 100 in Books) #44 in Books > Textbooks > Medicine & Health Sciences > Reference > Instruments & Supplies #79 in Books > Medical Books > Medicine > Reference > Instruments & Supplies #316 in Books > Textbooks > Medicine & Health Sciences > Allied Health Services > Medical Technology
This is a great book if you want to get into the depths of how to truly validate a medical device. But I want to strongly send a message to the publishers that the pricing is absolutely horrendous!! This book cost me over 200 dollars!!! For that price, I don't think it was worth it.
This a great book, if you work on Medical industry or want to know about it this book is for you!! It is easy to comprehend and as Engineer in Medical industry this book has been a lot of help. Don't think twice about it, must buy!!I gave it 4 stars due to the asking price, the book isn't big and the amount being asked for it is ridicolous, I bought it used for less than half the asking price
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