Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
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Book Description
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.
Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439
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Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author:
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 1528
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Book Description
Author: Ken Barat
Publisher: CRC Press
ISBN: 1420015540
Category : Technology & Engineering
Languages : en
Pages : 296
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Book Description
An effective laser safety program can mean big savings in time, money, effort, and most importantly, human well-being. It can improve the quality of your research program, your organization's reputation, and ultimately, improve your bottom line. Based on the extensive experience of active Laser Safety Officer Kenneth Barat, Laser Safety Management provides practical tools for successfully implementing a laser safety program in any environment. The book defines the three elements of laser safety: users, the laser safety officer, and incidental personnel. It covers the types of laser injuries, standard operating procedures to ensure safety, tips and tools to avoid pitfalls, training, control measures, and personal protection equipment. The author explores the laser safety officer position and delineates the required elements of effective SOPs. He also discusses non-beam hazards, includes practical control examples and sample forms, and covers U.S. and European regulations and standards. Taking a pedagogical approach, the book covers not only how to avoid accidents, but how to investigate them if they do occur. It includes a sample safety program designed to evaluate your current safety plan and act as a roadmap for where you need to be and how to get there. Filled with common sense solutions for laser safety issues, the book makes setting up a safety program practically painless.
Author:
Publisher:
ISBN:
Category : Catalogs, Publishers'
Languages : en
Pages : 616
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Author:
Publisher:
ISBN:
Category : Catalogs, Publishers'
Languages : en
Pages : 1114
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Book Description
Author: Joint Commission Resources
Publisher:
ISBN: 9781635852448
Category :
Languages : en
Pages :
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Author: Montana
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 1572
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Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 492
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Author:
Publisher:
ISBN:
Category : Industrial hygiene
Languages : en
Pages : 274
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Book Description
