Téléchargez le livre : Significant and Nonsignificant Risk Medical Devices

Significant and Nonsignificant Risk Medical Devices

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Springer


Paru le : 2024-08-01

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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.
Pages
433 pages
Collection
n.c
Parution
2024-08-01
Marque
Springer
EAN papier
9783031528378
EAN PDF
9783031528385
Informations sur l'ebook
Nombre pages copiables
4
Nombre pages imprimables
43
Taille du fichier
14920 Ko
Prix
116,04 €
EAN EPUB
9783031528385
Informations sur l'ebook
Nombre pages copiables
4
Nombre pages imprimables
43
Taille du fichier
17060 Ko
Prix
116,04 €

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