| 书目名称 | Significant and Nonsignificant Risk Medical Devices |
| 编辑 | Prakash Srinivasan Timiri Shanmugam,Pugazhenthan T |
| 视频video | |
| 概述 | An essential resource for researchers and professionals in the medical device field;.Thoroughly covers the distinctions between Significant Risk (SR) and Non-Significant Risk (NSR) device studies;.Pre |
| 图书封面 |  |
| 描述 | 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.. |
| 出版日期 | Book 2024 |
| 关键词 | Biomedical research; Clinical research; Medical device design; Significant Risk Device (SR); Nonsignific |
| 版次 | 1 |
| doi | https://doi.org/10.1007/978-3-031-52838-5 |
| isbn_softcover | 978-3-031-52840-8 |
| isbn_ebook | 978-3-031-52838-5 |
| copyright | The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl |
发表于 2025-3-21 17:22:28
