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Author : United States. Bureau of Medical Devices and Diagnostic Products
Publisher : Unknown
Page : 24 pages
File Size : 50,7 Mb
Release : 1976
Category : Medical instruments and apparatus
ISBN : UCR:31210023586173
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 46,7 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906
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 : Anonim
Publisher : Unknown
Page : 48 pages
File Size : 53,5 Mb
Release : 1990
Category : Diagnosis, Laboratory
ISBN : UOM:39015019576571
Author : Charles Sidebottom
Publisher : CRC Press
Page : 616 pages
File Size : 42,7 Mb
Release : 2019-08-30
Category : Electronic
ISBN : 0367395169
Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.
Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Page : 620 pages
File Size : 53,5 Mb
Release : 2022-01-27
Category : Medical
ISBN : 9781000440539
This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 42,8 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188
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.
Author : United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture and Related Agencies
Publisher : Unknown
Page : 1306 pages
File Size : 51,7 Mb
Release : 1978
Category : Electronic
ISBN : UCAL:$B656738
Author : United States. Congress. Senate. Committee on Appropriations. Subcommittee on Agriculture and Related Agencies
Publisher : Unknown
Page : 1292 pages
File Size : 50,8 Mb
Release : 1977
Category : Electronic
ISBN : MINN:31951D002838163
Author : Annetine C. Gelijns
Publisher : National Academies
Page : 78 pages
File Size : 47,7 Mb
Release : 1989
Category : Clinical medicine
ISBN : NAP:13516
Author : Institute of Medicine,Committee on Technological Innovation in Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 49,5 Mb
Release : 1990-02-01
Category : Medical
ISBN : 9780309042864
The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Author : Gloria Hall
Publisher : Unknown
Page : 128 pages
File Size : 44,6 Mb
Release : 2021-07-23
Category : Electronic
ISBN : 1947493671
Author : Jelena Madir
Publisher : Edward Elgar Publishing
Page : 394 pages
File Size : 40,5 Mb
Release : 2020-10-30
Category : Law
ISBN : 9781839104909
This comprehensive book provides a detailed survey and practical examination of a wide range of legal and regulatory topics in HealthTech. Key features include: • Analysis of the impact of emerging innovations on the accessibility, efficiency and quality of healthcare and its effects on healthcare providers • Examination of artificial intelligence, blockchain and digital identity applications in healthcare, alongside associated regulatory challenges • Guidance on the financial requirements of healthcare start-ups at different stages of growth and various collaboration and partnership models in the HealthTech market • Discussion of the major regulatory questions affecting the HealthTech industry, from data protection, public procurement and product liability, to the regulation of medical devices, intellectual property and advertising.
Author : World Health Organization
Publisher : World Health Organization
Page : 73 pages
File Size : 49,7 Mb
Release : 2019-05-16
Category : Medical
ISBN : 9789241210263
The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
Author : Steli Loznen,Constantin Bolintineanu
Publisher : Artech House
Page : 350 pages
File Size : 50,7 Mb
Release : 2021-09-30
Category : Technology & Engineering
ISBN : 9781630818395
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 318 pages
File Size : 46,6 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458
Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
