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Medical Device Regulations
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Medical Device Regulations : A Complete Guide

Book Details

Format Paperback / Softback
ISBN-10 0323911269
ISBN-13 9780323911269
Publisher Elsevier Science & Technology
Imprint Academic Press Inc
Country of Manufacture NL
Country of Publication GB
Publication Date Jan 20th, 2022
Print length 186 Pages
Weight 400 grams
Dimensions 23.50 x 19.10 x 1.40 cms
Ksh 22,150.00
Manufactured on Demand 0 in stock

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Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements.

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