Significant and Nonsignificant Risk Medical Devices
Significant and Nonsignificant Risk Medical Devices
English | 2024 | ISBN: 3031528379 | 752 Pages | PDF EPUB (True) | 31 MB
English | 2024 | ISBN: 3031528379 | 752 Pages | PDF EPUB (True) | 31 MB
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.