Significant and Nonsignificant Risk Medical Devices

Name: Significant and Nonsignificant Risk Medical Devices
Brand: Springer
Availability: OutOfStock
Rating: 5 (1 reviews)

By Timiri Shanmugam, Prakash Srinivasan

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Description

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.

Product details

Binding:: Paperback
Number of Pages:: 444
Release Date:: 2025-08-02
Publication Date:: 2025-08-02
Publisher:: Springer
Languages:: Original: English
ISBN10:: 3031528409
ISBN13:: 9783031528408
GPSR Manufacturer Reference:: [email protected]
Weight:: 668 g
Height:: 155 cm
Width:: 235 cm
Thickness:: 24 cm

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