Medical Devices Law and Regulation Answer Book
Title | Medical Devices Law and Regulation Answer Book PDF eBook |
Author | Susan Onel |
Publisher | |
Pages | 1112 |
Release | 2016-11 |
Genre | Medical instruments and apparatus |
ISBN | 9781402427749 |
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Innovation and Protection
Title | Innovation and Protection PDF eBook |
Author | I. Glenn Cohen |
Publisher | Cambridge University Press |
Pages | 295 |
Release | 2022-04-07 |
Genre | Law |
ISBN | 1108838634 |
A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Public Health Effectiveness of the FDA 510(k) Clearance Process
Title | Public Health Effectiveness of the FDA 510(k) Clearance Process PDF eBook |
Author | Institute of Medicine |
Publisher | National Academies Press |
Pages | 141 |
Release | 2010-10-04 |
Genre | Medical |
ISBN | 0309162904 |
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.
Medical Device Regulations
Title | Medical Device Regulations PDF eBook |
Author | Michael Cheng |
Publisher | World Health Organization |
Pages | 54 |
Release | 2003-09-16 |
Genre | Medical |
ISBN | 9241546182 |
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.
Medical Device Design and Regulation
Title | Medical Device Design and Regulation PDF eBook |
Author | Carl T. DeMarco |
Publisher | Quality Press |
Pages | 369 |
Release | 2011-01-01 |
Genre | Business & Economics |
ISBN | 0873898168 |
Medical Devices
Title | Medical Devices PDF eBook |
Author | Seeram Ramakrishna |
Publisher | Woodhead Publishing |
Pages | 253 |
Release | 2015-08-18 |
Genre | Medical |
ISBN | 0081002912 |
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
Medical Device Development
Title | Medical Device Development PDF eBook |
Author | Jonathan S. Kahan |
Publisher | |
Pages | 658 |
Release | 2020 |
Genre | Medical instruments and apparatus |
ISBN | 9780996346276 |