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Author : Donald J. Lecraw
Publisher : Ottawa, Ont. : Economic Council of Canada
Page : 190 pages
File Size : 40,5 Mb
Release : 1981
Category : Commercial products
ISBN : STANFORD:36105128632457
Author : Michael Cheng,World Health Organization
Publisher : Diamond Pocket Books (P) Ltd.
Page : 58 pages
File Size : 45,9 Mb
Release : 2003-09-16
Category : 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.
Author : Jonathan Black
Publisher : CRC Press
Page : 520 pages
File Size : 48,6 Mb
Release : 2005-12-20
Category : Medical
ISBN : 9781420057843
Bioengineers need a thorough grounding in biocompatibility - the biological performance of materials. Until now, there were no publications suitable for a neophyte in the field; prior publications were either not comprehensive or focused on rather narrow interests. Drawing on the author's 35 years of experience as a teacher, researcher, and consult
Author : United States. Food and Drug Administration
Publisher : Unknown
Page : 336 pages
File Size : 50,9 Mb
Release : 2024-07-01
Category : Medical instruments and apparatus
ISBN : MINN:30000010715898
Author : Division on Engineering and Physical Sciences,Commission on Physical Sciences, Mathematics, and Applications,Committee on Hazardous Biological Substances in the Laboratory,National Research Council
Publisher : National Academies Press
Page : 237 pages
File Size : 46,7 Mb
Release : 1989-01-01
Category : Science
ISBN : 9780309039758
Biosafety in the Laboratory is a concise set of practical guidelines for handling and disposing of biohazardous material. The consensus of top experts in laboratory safety, this volume provides the information needed for immediate improvement of safety practices. It discusses high- and low-risk biological agents (including the highest-risk materials handled in labs today), presents the "seven basic rules of biosafety," addresses special issues such as the shipping of dangerous materials, covers waste disposal in detail, offers a checklist for administering laboratory safetyâ€"and more.
Author : Elijah Wreh
Publisher : Elsevier
Page : 680 pages
File Size : 48,9 Mb
Release : 2023-02-22
Category : Technology & Engineering
ISBN : 9780323953535
Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medical device, which agencies regulate medical devices, how policies regarding regulation affect the market, rules regarding marketing, and laws and standards that govern testing. This practical, well-structured reference tool helps medical device manufacturers both in and out of the United States with premarket application and meeting complex FDA regulatory requirements. The book delivers a comprehensive overview of the field from an author with expertise in regulatory affairs and commercialization of medical devices. Offers a unique focus on the regulatory affairs industry, specifically targeted at regulatory affairs professionals and those seeking certification Puts regulations in the context of contemporary design Includes case studies and applications of regulations
Author : United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust and Monopoly
Publisher : Unknown
Page : 1472 pages
File Size : 47,9 Mb
Release : 1977
Category : Consumer protection
ISBN : STANFORD:36105045486441
Author : Anonim
Publisher : Unknown
Page : 266 pages
File Size : 43,7 Mb
Release : 1984
Category : Government publications
ISBN : UCR:31210015700550
Author : Anonim
Publisher : Unknown
Page : 956 pages
File Size : 43,9 Mb
Release : 2017
Category : Administrative law
ISBN : OSU:32437123595700
Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
Author : Buddy D. Ratner,Allan S. Hoffman,Frederick J. Schoen,Jack E. Lemons
Publisher : Academic Press
Page : 1573 pages
File Size : 55,8 Mb
Release : 2012-12-31
Category : Medical
ISBN : 9780080877808
The revised edition of this renowned and bestselling title is the most comprehensive single text on all aspects of biomaterials science. It provides a balanced, insightful approach to both the learning of the science and technology of biomaterials and acts as the key reference for practitioners who are involved in the applications of materials in medicine. Over 29,000 copies sold, this is the most comprehensive coverage of principles and applications of all classes of biomaterials: "the only such text that currently covers this area comprehensively" - Materials Today Edited by four of the best-known figures in the biomaterials field today; fully endorsed and supported by the Society for Biomaterials Fully revised and expanded, key new topics include of tissue engineering, drug delivery systems, and new clinical applications, with new teaching and learning material throughout, case studies and a downloadable image bank
Author : United States. Regulatory Council
Publisher : Unknown
Page : 212 pages
File Size : 52,5 Mb
Release : 1980
Category : Electronic
ISBN : HARVARD:32044032166266
Author : L Hench,J. Jones
Publisher : Elsevier
Page : 298 pages
File Size : 40,9 Mb
Release : 2005-09-27
Category : Science
ISBN : 9781845690861
Maintaining quality of life in an ageing population is one of the great challenges of the 21st Century. This book summarises how this challenge is being met by multi-disciplinary developments of specialty biomaterials, devices, artificial organs and in-vitro growth of human cells as tissue engineered constructs. Biomaterials, Artificial Organs and Tissue Engineering is intended for use as a textbook in a one semester course for upper level BS, MS and Meng students. The 25 chapters are organized in five parts: Part one provides an introduction to living and man-made materials for the non-specialist; Part two is an overview of clinical applications of various biomaterials and devices; Part three summarises the bioengineering principles, materials and designs used in artificial organs; Part four presents the concepts, cell techniques, scaffold materials and applications of tissue engineering; Part five provides an overview of the complex socio-economic factors involved in technology based healthcare, including regulatory controls, technology transfer processes and ethical issues. Comprehensive introduction to living and man-made materials Looks at clinical applications of various biomaterials and devices Bioengineering principles, materials and designs used in artificial organs are summarised
Author : American Society for Quality Control,American Society for Quality Control. Technical Conference
Publisher : Unknown
Page : 752 pages
File Size : 53,6 Mb
Release : 1978
Category : Chemical industry
ISBN : UOM:39015037932079
Author : Ross E. Cheit
Publisher : Univ of California Press
Page : 316 pages
File Size : 42,7 Mb
Release : 1990-01-01
Category : Political Science
ISBN : 0520067339
"This is an extremely rich piece of scholarship that blends the perspectives of law, economics, engineering, and political science in comparing public and private standard-setting."--Peter J. May, University of Washington "The book is of first-rate importance because it does an impeccable job of presenting and analyzing previously unknown and woefully neglected material essential to the ongoing risk debate."--Aaron Wildavsky, author of The Deficit and the Public Interest
Author : Anonim
Publisher : Unknown
Page : 1358 pages
File Size : 48,8 Mb
Release : 1977
Category : Delegated legislation
ISBN : UCR:31210024961680