Mastering Medical Device Regulation: A Comprehensive Guide for Regulatory Affairs Professionals

Stay up-to-date with the latest FDA-CDRH thinking on medical device regulation with this authoritative guide written by renowned expert Elijah Wreh.

What is Medical Device Regulation?

Medical Device Regulation provides vital insights into the world of medical devices, covering essential topics such as:

• Criteria for identifying medical devices
• Regulatory agencies involved in medical device oversight
• Policies affecting the medical device market
• Marketing rules and regulations
• Laws and standards governing medical device testing

A Valuable Resource for Medical Device Manufacturers

This practical reference tool is specifically designed to help medical device manufacturers, both in the US and globally, navigate the complex FDA regulatory landscape, including premarket application and compliance requirements.

Written by an expert in regulatory affairs and commercialization of medical devices, this book offers a unique perspective on the regulatory affairs industry, making it an indispensable resource for:

• Regulatory affairs professionals seeking certification
• Companies looking to stay ahead of the curve in medical device development and commercialization

Key Features

This comprehensive guide includes:

• Case studies and real-world applications of medical device regulations
• Contextualized regulations, put into perspective with contemporary design and development considerations

Published by Elsevier Science, this authoritative guide is available in English and features:

• ISBN: 9780323953542 (hardcover)
• ISBN: 9780323953535 (paperback)

Published on February 22, 2023, this book is a must-have for anyone involved in the medical device industry, offering a comprehensive overview of the field and expert insights into the regulatory landscape.