Download or read book Manufacture Packing Storage and Installation of Medical Devices written by United States Department of Health, Education, and Welfare. Food and Drug Administration and published by . This book was released on 1978 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Food and Drug Administration s Good Manufacturing Practice for the Manufacture Packing Storage and Installation of Medical Devices written by United States. Food and Drug Administration and published by . This book was released on 1987-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Economic Impact Assessment of Final Rulemaking written by United States. Bureau of Medical Devices and published by . This book was released on 1978 with total page 50 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. 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.
Download or read book Medical Devices written by United States. Food and Drug Administration and published by . This book was released on with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Medical Device Federal Register Documents June 4 1976 Through April 8 1986 written by and published by . This book was released on 1986 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Device Good Manufacturing Practices written by United States. Bureau of Medical Devices. Division of Compliance Programs and published by . This book was released on 1979 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Federal Register written by and published by . This book was released on 1978-07 with total page 1554 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Import export of Medical Devices written by and published by . This book was released on 1983 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Medical Device Industry written by Norman F. Estrin and published by CRC Press. This book was released on 1990-08-31 with total page 1020 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach
Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.
Download or read book Validating Medical Packaging written by Ronald Pilchik and published by CRC Press. This book was released on 2002-09-27 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file. About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging.
Download or read book Federal Register written by and published by . This book was released on 2004-06-14 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Device Good Manufacturing Practices written by United States. Bureau of Medical Devices and published by . This book was released on 1978 with total page 96 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory Requirements for Medical Devices written by and published by . This book was released on 1983 with total page 440 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book FDA Consumer written by and published by . This book was released on 1999 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt:
