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    3. Significant and Nonsignificant Risk Medical Devices

    Significant and Nonsignificant Risk Medical Devices

    Posted By: hill0
    Date: 3 Aug 2024 05:39:41
    Significant and Nonsignificant Risk Medical Devices

    Significant and Nonsignificant Risk Medical Devices
    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.
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