Significant and Nonsignificant Risk Medical Devices

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.

• | Author: Prakash Srinivasan Timiri Shanmugam, Thangaraju Pugazhenthan, Thamizharasan Sampath, Indumathy Jagadeeswaran
• | Publisher: Springer
• | Publication Date: Aug 02, 2024
• | Number of Pages: NA pages
• | Language: English
• | Binding: Hardcover
• | ISBN-10: 3031528379
• | ISBN-13: 9783031528378