显著风险和非显著风险医疗器械

English | 2024 | ISBN-10: 3031528379 | 441 pages| Epub PDF (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. 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

这本综合资源解释了FDA对设备的分类，并提供了专家指导，帮助区分重大风险和非重大风险医疗器械研究。本书分为两部分：重大风险医疗设备和非重大风险医疗设备。每一章都包括对该设备的一般介绍及其工作原理、有益和毒理学效应以及可能对患者/受试者健康和安全的风险的指导。此外，它还涵盖了关于风险确定的基础报告以及使用个别设备时潜在危害的性质。 《重大风险与非重大风险医疗器械》旨在帮助临床工程师、学术研究人员和临床调查人员在医疗设备研究和开发中导航复杂的监管环境。

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