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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.
About the Author: Interpharm
Title: Compact Regs Parts 807, 812 and 814 : Cfr 21...
Publisher: CRC Press
Publication Date: 2018
Binding: Hardcover
Condition: New
Edition: 2nd Edition
Seller: AHA-BUCH GmbH, Einbeck, Germany
Buch. Condition: Neu. Neuware. Seller Inventory # 9781138407282
Seller: Mispah books, Redhill, SURRE, United Kingdom
hardcover. Condition: New. NEW. SHIPS FROM MULTIPLE LOCATIONS. book. Seller Inventory # ERICA80011384072836