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Author :
Publisher :
ISBN 13 :
Total Pages : 48 pages
Book Rating : 4.71/5 ( download)
Download or read book Guideline for the Manufacture of in Vitro Diagnostic Products written by and published by . This book was released on 1990 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Center for Devices and Radiological Health (U.S.)
Publisher :
ISBN 13 :
Total Pages : 28 pages
Book Rating : 4.73/5 ( download)
Download or read book GMP Guidelines for the Manufacture of in Vitro Diagnostic Products written by Center for Devices and Radiological Health (U.S.) and published by . This book was released on 1988 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Alfred Bracey
Publisher :
ISBN 13 :
Total Pages : 78 pages
Book Rating : 4.82/5 ( download)
Download or read book In Vitro Diagnostic Devices written by Alfred Bracey and published by . This book was released on 1987 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : James F. Pierson-Perry
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.11/5 ( download)
Download or read book Evaluation of Stability of in Vitro Diagnostic Reagents written by James F. Pierson-Perry and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "provides guidance and regression-based procedures for establishing stability-related claims on in vitro diagnostic (IVD) reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies, but will also be of interest to clinincal laboratories"--Cover.
Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 62 pages
Book Rating : 4.78/5 ( download)
Download or read book FDA Biotechnology Inspection Guide written by United States. Food and Drug Administration and published by . This book was released on 1991 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309162904
Total Pages : 141 pages
Book Rating : 4.06/5 ( download)
Download or read book Public Health Effectiveness of the FDA 510(k) Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Stefanos Zenios
Publisher : Cambridge University Press
ISBN 13 : 0521517427
Total Pages : 779 pages
Book Rating : 4.23/5 ( download)
Download or read book Biodesign written by Stefanos Zenios and published by Cambridge University Press. This book was released on 2010 with total page 779 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.
Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.00/5 ( download)
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.60/5 ( download)
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author : Michael Cheng
Publisher : World Health Organization
ISBN 13 : 9241546182
Total Pages : 54 pages
Book Rating : 4.88/5 ( download)
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.
