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Author : Mdr
Publisher : Physician's Desk Reference (PDR)
ISBN 13 : 9781563632624
Total Pages : 1568 pages
Book Rating : 4.6/5 (326 download)
Download or read book 1998 Medical Device Register written by Mdr and published by Physician's Desk Reference (PDR). This book was released on 1998 with total page 1568 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : G.R Higson
Publisher : CRC Press
ISBN 13 : 1040053939
Total Pages : 192 pages
Book Rating : 4.0/5 (4 download)
Download or read book Medical Device Safety written by G.R Higson and published by CRC Press. This book was released on 2001-10-29 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Author : MDR Staff
Publisher : Physician's Desk Reference (PDR)
ISBN 13 : 9781563632631
Total Pages : 0 pages
Book Rating : 4.6/5 (326 download)
Download or read book Medical Device Register 1998 written by MDR Staff and published by Physician's Desk Reference (PDR). This book was released on 1998 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: For those interested in medical supplies and companies outside the US, this resource covers more than 7,000 suppliers and 25,000 products from over 70 countries including Canada. Whether it's to locate overseas distributors for your company's products or to identify product licensing or acquisition opportunities, this edition aims to provide a comprehensive reference to the international arena. Organized in the same easy format as the US edition the MDR international edition aims to save the reader valuable research time.
Author :
Publisher :
ISBN 13 :
Total Pages : 1658 pages
Book Rating : 4.:/5 (318 download)
Download or read book Medical Device Register written by and published by . This book was released on 2005 with total page 1658 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309096316
Total Pages : 481 pages
Book Rating : 4.3/5 (9 download)
Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Author : United States. General Accounting Office
Publisher :
ISBN 13 :
Total Pages : 40 pages
Book Rating : 4.:/5 (31 download)
Download or read book Medical Devices written by United States. General Accounting Office and published by . This book was released on 1998 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 9814411221
Total Pages : 610 pages
Book Rating : 4.8/5 (144 download)
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2013-03-27 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process dem
Author : Center for Devices and Radiological Health (U.S.). Office of Compliance and Surveillance
Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.3/5 ( download)
Download or read book Medical Device Establishment Registration written by Center for Devices and Radiological Health (U.S.). Office of Compliance and Surveillance and published by . This book was released on 1987 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Anthony C. Cartwright
Publisher : CRC Press
ISBN 13 : 1420081837
Total Pages : 804 pages
Book Rating : 4.4/5 (2 download)
Download or read book International Pharmaceutical Product Registration written by Anthony C. Cartwright and published by CRC Press. This book was released on 2016-04-19 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Author :
Publisher :
ISBN 13 :
Total Pages : 378 pages
Book Rating : 4.3/5 (121 download)
Download or read book Federal Register written by and published by . This book was released on 2012-08 with total page 378 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Mdr
Publisher : Canon Communications, LLC
ISBN 13 : 9781884551185
Total Pages : pages
Book Rating : 4.5/5 (511 download)
Download or read book Medical Device Register written by Mdr and published by Canon Communications, LLC. This book was released on 2006-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Medical Economics
Publisher : Physician's Desk Reference (PDR)
ISBN 13 : 9781563633058
Total Pages : 3200 pages
Book Rating : 4.6/5 (33 download)
Download or read book 1999 Medical Device Register written by Medical Economics and published by Physician's Desk Reference (PDR). This book was released on 1999-01-01 with total page 3200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now you can make reliable purchasing decisions and product comparisons 1999 resource
Author :
Publisher :
ISBN 13 :
Total Pages : 1692 pages
Book Rating : 4.:/5 (318 download)
Download or read book Medical Device Register written by and published by . This book was released on 2007 with total page 1692 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contains a list of all manufacturers and other specified processors of medical devices registered with the Food and Drug Administration, and permitted to do business in the U.S., with addresses and telephone numbers. Organized by FDA medical device name, in alphabetical order. Keyword index to FDA established standard names of medical devices.
Author :
Publisher :
ISBN 13 :
Total Pages : 354 pages
Book Rating : 4.0/5 ( download)
Download or read book Official Gazette of the United States Patent and Trademark Office written by and published by . This book was released on 2004 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309212456
Total Pages : 318 pages
Book Rating : 4.3/5 (92 download)
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.
Author : United States. Food and Drug Administration. Task Force on Risk Management
Publisher :
ISBN 13 :
Total Pages : 172 pages
Book Rating : 4.:/5 (319 download)
Download or read book Managing the Risks from Medical Product Use written by United States. Food and Drug Administration. Task Force on Risk Management and published by . This book was released on 1999 with total page 172 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Jack Wong
Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
