This book provides insights into the causes of failures to comply with the quality regulations of the Food and Drug Administration. It describes the reasons for the compliance failures and the actions that can be taken to assure that the FDA quality auditor does not discover significant observations of nonconformance.
Book Description
Editorial Reviews
From the Publisher
Mort Levin is an acknowledged authority in the actions necessary for compliance with the quality regulations of the Food and Drug Administration. Most of his industry career of over thirty years as a designer, manager of design, and manager of quality and regulatory affairs has been devoted to assuring the only quality medical devices were designed and manufactured.
From the Author
For the last several years of my industry career, I was the worldwide manager of quality and regulatory affairs for the Medical Products Group of Hewlett Packard Company.I have been President and Chairman of the Association for the Advancement of Medical Instrumentation and have been active in the development of domestic and international standards for electrical medical devices. I have contributed to the IEEE White Book on Electrical Systems in Healthcare and to the Handbook of Biomedical Engineering.
Product Details
Would you like to update product info or give feedback on images?
|
More About the Author
Discover books, learn about writers, read author blogs, and more.
Customer Reviews
|
There are no customer reviews yet.
|
|||
|
Video reviews
|
Tag this product(What's this?)Think of a tag as a keyword or label you consider is strongly related to this product.
Tags will help all customers organize and find favorite items. |
Sell a Digital Version of This Book in the Kindle Store
If you are a publisher or author and hold the digital rights to a book, you can sell a digital version of it in our Kindle Store.
Learn more
Customer Discussions
|
This product's forum
Active discussions in related forums
Search Customer Discussions
|
Related forums
|
