Significant and Nonsignificant Risk Medical Devices

Book Overview

This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.

Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.

• Format: Hardcover
• Language: English
• ISBN: 3031528379
• ISBN13: 9783031528378
• Release Date: August 2024
• Publisher: Springer
• Length: 433 Pages
• Weight: 1.75 lbs.
• Dimensions: 1.0" x 6.1" x 9.2"