Voluntary Standards As A Regulatory Device
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Voluntary Standards as a Regulatory Device
Author | : Donald J. Lecraw |
Publsiher | : Ottawa, Ont. : Economic Council of Canada |
Total Pages | : 190 |
Release | : 1981 |
Genre | : Commercial products |
ISBN | : STANFORD:36105128632457 |
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Medical Device Regulations
Author | : Michael Cheng,World Health Organization |
Publsiher | : Diamond Pocket Books (P) Ltd. |
Total Pages | : 58 |
Release | : 2003-09-16 |
Genre | : Medical |
ISBN | : 9241546182 |
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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.
Biological Performance of Materials
Author | : Jonathan Black |
Publsiher | : CRC Press |
Total Pages | : 520 |
Release | : 2005-12-20 |
Genre | : Medical |
ISBN | : 9781420057843 |
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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
Medical Devices
Author | : United States. Food and Drug Administration |
Publsiher | : Unknown |
Total Pages | : 336 |
Release | : 2024 |
Genre | : Medical instruments and apparatus |
ISBN | : MINN:30000010715898 |
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Biosafety in the Laboratory
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 |
Publsiher | : National Academies Press |
Total Pages | : 237 |
Release | : 1989-01-01 |
Genre | : Science |
ISBN | : 9780309039758 |
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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.
Medical Device Regulation
Author | : Elijah Wreh |
Publsiher | : Elsevier |
Total Pages | : 680 |
Release | : 2023-02-22 |
Genre | : Technology & Engineering |
ISBN | : 9780323953535 |
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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
Voluntary Standards and Accreditation Act of 1977 S 825
Author | : United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust and Monopoly |
Publsiher | : Unknown |
Total Pages | : 1472 |
Release | : 1977 |
Genre | : Consumer protection |
ISBN | : STANFORD:36105045486441 |
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Federal Policies and the Medical Devices Industry
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 266 |
Release | : 1984 |
Genre | : Government publications |
ISBN | : UCR:31210015700550 |
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