Description: Medical Device Regulations : A Complete Guide, Paperback by Deep, Aakash, ISBN 0323911269, ISBN-13 9780323911269, Like New Used, Free shipping in the US
Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. Th 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.
- Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries
- Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan)
- Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products
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End Time: 2025-01-26T11:51:00.000Z
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Book Title: Medical Device Regulations : A Complete Guide
Number of Pages: 200 Pages
Publication Name: Medical Device Regulations : a Complete Guide
Language: English
Publisher: Elsevier Science & Technology
Subject: Engineering (General), General
Publication Year: 2022
Type: Textbook
Subject Area: Law, Technology & Engineering
Author: Aakash Deep
Item Length: 9.2 in
Item Width: 7.5 in
Format: Trade Paperback
