Produktnummer:
18111e4acad8754fc49ac1814a206dd701
| Themengebiete: | Biomedical research Clinical research Food and Drug Administration (FDA) IDE 21 CFR 812 IDE 21 CFR 812.2(b) Institutional Review Boards (IRB) Investigational Device Exemptions (IDE) Medical device design Nonsignificant Risk Device (NSR) Significant Risk Device (SR) |
|---|---|
| Veröffentlichungsdatum: | 01.08.2024 |
| EAN: | 9783031528385 |
| Sprache: | Englisch |
| Seitenzahl: | 433 |
| Produktart: | Unbekannt |
| Herausgeber: | Jagadeeswaran, Indumathy Sampath, Thamizharasan Thangaraju, Pugazhenthan Timiri Shanmugam, Prakash Srinivasan |
| Verlag: | Springer International Publishing |
Produktinformationen "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.
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