Name: Significant and Nonsignificant Risk Medical Devices (en Inglés)
SKU: 57742572
Price: 113.19 USD
Availability: InStock
Author: Timiri Shanmugam, Prakash Srinivasan ; Thangaraju, Pugazhenthan ; Sampath, Thamizharasan
ISBN: 9783031528378

portada Significant and Nonsignificant Risk Medical Devices (en Inglés)

Significant and Nonsignificant Risk Medical Devices (en Inglés)

Formato

Libro Físico

Editorial

Springer

Autor

Timiri Shanmugam, Prakash Srinivasan ; Thangaraju, Pugazhenthan ; Sampath, Thamizharasan

Idioma

Inglés

N° páginas

448

Encuadernación

Tapa Dura

ISBN13

9783031528378

Categorías

Investigación médica
Medicina clínica e interna
Ingeniería biomédica
Biotecnología

Significant and Nonsignificant Risk Medical Devices (en Inglés)

Timiri Shanmugam, Prakash Srinivasan ; Thangaraju, Pugazhenthan ; Sampath, Thamizharasan (Autor) · Springer · Tapa Dura

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Reseña del libro "Significant and Nonsignificant Risk Medical Devices (en Inglés)"

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.