1# Library to Find Best eBook for Read
Author : Suzan Onel
Release : 2022
Genre : Medical instruments and apparatus
Kind : eBook
Book Rating : 622/5 ( reviews)
Book Synopsis Medical Devices Law and Regulation Answer Book by : Suzan Onel
Download or read book Medical Devices Law and Regulation Answer Book written by Suzan Onel. This book was released on 2022. Available in PDF, EPUB and Kindle. Book excerpt:
Author : I. Glenn Cohen
Release : 2022-04-07
Genre : Law
Kind : eBook
Book Rating : 634/5 ( reviews)
Book Synopsis Innovation and Protection by : I. Glenn Cohen
Download or read book Innovation and Protection written by I. Glenn Cohen. This book was released on 2022-04-07. Available in PDF, EPUB and Kindle. Book excerpt: A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Author : Institute of Medicine
Release : 2010-10-04
Genre : Medical
Kind : eBook
Book Rating : 904/5 ( reviews)
Book Synopsis Public Health Effectiveness of the FDA 510(k) Clearance Process by : Institute of Medicine
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine. This book was released on 2010-10-04. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.
Author : Seeram Ramakrishna
Release : 2015-08-18
Genre : Medical
Kind : eBook
Book Rating : 912/5 ( reviews)
Book Synopsis Medical Devices by : Seeram Ramakrishna
Download or read book Medical Devices written by Seeram Ramakrishna. This book was released on 2015-08-18. Available in PDF, EPUB and Kindle. Book excerpt: Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process
Author : Michael Cheng
Release : 2003-09-16
Genre : Medical
Kind : eBook
Book Rating : 182/5 ( reviews)
Book Synopsis Medical Device Regulations by : Michael Cheng
Download or read book Medical Device Regulations written by Michael Cheng. This book was released on 2003-09-16. Available in PDF, EPUB and Kindle. Book excerpt: The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.
