Medical Devices Law and Regulation Answer Book
- ISBN-10
- 1402427743
- ISBN-13
- 9781402427749
- Category
- Medical instruments and apparatus
- Pages
- 1112
- Language
- English
- Published
- 2016-11
- Authors
- Susan Onel, Karen M. Becker
Description
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
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