Guideline For The Manufacture Of In Vitro Diagnostic Products
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Guideline for the Manufacture of in Vitro Diagnostic Products
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 48 |
Release | : 1990 |
Genre | : Diagnosis, Laboratory |
ISBN | : UOM:39015019576571 |
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Biodesign
Author | : Stefanos Zenios,Josh Makower,Paul Yock |
Publsiher | : Cambridge University Press |
Total Pages | : 779 |
Release | : 2010 |
Genre | : Medical |
ISBN | : 9780521517423 |
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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.
Medical Device Regulations
Author | : Michael Cheng,World Health Organization |
Publsiher | : World Health Organization |
Total Pages | : 54 |
Release | : 2003-09-16 |
Genre | : Medical |
ISBN | : 9789241546188 |
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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.
The Biomedical Quality Auditor Handbook Third Edition
Author | : Heather Crawford |
Publsiher | : Quality Press |
Total Pages | : 300 |
Release | : 2017-09-08 |
Genre | : Business & Economics |
ISBN | : 9780873899628 |
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The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQs Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
Fortieth Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 0 |
Release | : 2006 |
Genre | : Quality control |
ISBN | : 9241209372 |
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Dietary Supplements
Author | : United States. Federal Trade Commission. Bureau of Consumer Protection |
Publsiher | : Unknown |
Total Pages | : 32 |
Release | : 1998 |
Genre | : Advertising |
ISBN | : UIUC:30112004816200 |
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Federal Register
Author | : Anonim |
Publsiher | : Unknown |
Total Pages | : 342 |
Release | : 2018 |
Genre | : Delegated legislation |
ISBN | : OSU:32437123718203 |
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Rare Diseases and Orphan Products
Author | : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development |
Publsiher | : National Academies Press |
Total Pages | : 442 |
Release | : 2011-04-03 |
Genre | : Medical |
ISBN | : 9780309158060 |
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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.