biomedical engineering regulation
Category=PS
clinical trials devices
compliance auditing
device manufacturing standards
eq_bestseller
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
eq_non-fiction
eq_science
quality system regulation
regulatory documentation
US FDA device regulatory framework
Product details
- ISBN 9780849322037
- Weight: 1580g
- Dimensions: 96 x 140mm
- Publication Date: 17 Nov 2003
- Publisher: Taylor & Francis Inc
- Publication City/Country: US
- Product Form: Paperback
Secure
checkout
Fast Shipping
Easy returns
Supplemented with a convenient keyword index, this book provides a pocket-sized verbatim reproduction of key US FDA regulations. It presents the requirements as set forth by the FDA CFR 21 Parts 807, 812, and 814 to sell or distribute medical devices, including the pre-market approval requirements for the devices. The easy-to-use format that puts the exact section of the reg required by medical device manufacturers within easy reach. This is the perfect low-cost tool for employees as part of documented training programs; suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements; and technicians charged with ensuring adherence to US FDA regulations.
