Kommande
Kropp & själ
Significant and Nonsignificant Risk Medical Devices
Prakash Srinivasan Timiri Shanmugam • Pugazhenthan Thangaraju • Thamizharasan Sampath • Indumathy Jagadeeswaran
Inbunden
2509:-
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: Inbunden
- ISBN: 9783031528378
- Språk: Engelska
- Antal sidor: 448
- Utgivningsdatum: 2024-07-17
- Förlag: Springer International Publishing AG