eShop USA > Books > The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices
from: ASQ Quality Press
List Price: $89.25Our Price: $69.97 You Save: $19.28 (22%)Prices subject to change.
Availability: Usually ships in 24 hours
Binding: Hardcover
Dewey Decimal Number: 344.73042
EAN: 9780873893770
ISBN: 0873893778
Label: ASQ Quality Press
Manufacturer: ASQ Quality Press
Number Of Items: 1
Number Of Pages: 210
Publication Date: 1996-10
Publisher: ASQ Quality Press
Studio: ASQ Quality Press
Related Items: Featured Listmania!
Customer Reviews
Average Rating: 
Rating:  - Summarizes FDA rules, but does not discuss them
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 ... Read More
Rating:  - Good at laying out the rules
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, ... Read More
Related Categories:
| |
 |
