Description
This comprehensive resource explains how devices are classified by the FDA and offers readers expert guidance on the differences between significant risk (SR) and non-significant risk (NSR) medical device studies. Divided into two parts Significant Risk Medical Devices and Nonsignificant Risk Medical Devices each chapter in the book provides a general introduction and overview of the device presented along with guidance on their working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. Coverage also looks at reports of prior investigations conducted on the basics of risk determination and the nature of potential harm from using individual devices. The Significant and Nonsignificant Risk Medical Device Handbook will assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.
