Mastering Medical Device Regulation: A Comprehensive Guide for Manufacturers

Stay up-to-date with the latest FDA-CDRH thinking on medical device regulation with “Medical Device Regulation” by Elijah Wreh, a renowned expert in regulatory affairs and commercialization of medical devices.

What You’ll Learn

• How to determine if a device meets the criteria for being a medical device
• Which agencies regulate medical devices and how they impact the market
• The rules and regulations governing marketing and testing of medical devices
• Laws and standards that govern testing and regulatory requirements for medical device manufacturers

This practical reference tool is specifically designed for medical device manufacturers, both in and out of the United States, to help them navigate the complexities of premarket application and FDA regulatory requirements.

What Sets This Book Apart

• A unique focus on the regulatory affairs industry, making it an essential resource for regulatory affairs professionals and those seeking certification
• Real-world case studies and applications of regulations, providing valuable insights and practical knowledge
• A comprehensive overview of the field, covering contemporary design and regulatory requirements

Published by Elsevier Science, this authoritative guide is available in English and can be easily referenced using the ISBN numbers: 9780323953542 and 9780323953535.

Get ready to master the complexities of medical device regulation and take your business to the next level.