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Essentials of Medical Device Clinical Research (Vol 1, 2 & 3)

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Book Details:

Author: Dr. Ashish Indani
Brand: B Jain Publication
Binding: Hardcover
Number of Pages: 875
Release Date: 01-12-2022
EAN: 9788131927830
Languages: English
Package Dimensions: 10.2 x 7.9 x 1.2 inches

Details:
"Essentials of Medical Device Clinical Research (Volume I & II)" by Dr. Ashish Indani is a comprehensive resource for clinical research professionals in the field of medical devices. This book addresses the unique challenges and complexities in the clinical research of medical devices compared to drugs, focusing on issues such as regulatory harmonization, the lifecycle of medical devices, and the evolving requirements in the medical device industry. Topics include preclinical studies, risk management, materiovigilance, clinical evidence, and more, with an in-depth exploration of medical device classifications, ISO standards, and the global marketing authorization process.