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Author: Gloria Hall
Publisher:
ISBN: 9781947493674
Category :
Languages : en
Pages :
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493674
Category :
Languages : en
Pages :
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Book Description
Author: Pamela A. Jones
Publisher:
ISBN: 9781947493377
Category : Medical instruments and apparatus
Languages : en
Pages : 672
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493490
Category : Medical instruments and apparatus
Languages : en
Pages : 726
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Book Description
Fundamentals of Medical Device Regulations is a compilation of history, medical device and in vitro diagnotic (IVD) medical device information from RAPS' regional publications: Fundamentals of US Regulatory Affairs, Eleventh Edition; Fundamentals of Canadian Medical Device Regulations; Fundamentals of EU Regulatory Affairs, Ninth Edition; Fundamentals of International Regulatory Affairs, Fourth Edition."--Foreword.
Author: Gloria Hall
Publisher:
ISBN: 9781947493278
Category :
Languages : en
Pages :
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Book Description
Author: Zeeshaan Arshad
Publisher:
ISBN: 9780997769715
Category :
Languages : en
Pages :
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Author: Carol Cooper
Publisher:
ISBN: 9780997769791
Category :
Languages : en
Pages :
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Book Description
Laws and regulations governing the manufacture and marketing of medical devices in the US.
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: Stephen F. Amato
Publisher: Elsevier
ISBN: 0857099205
Category : Medical
Languages : en
Pages : 202
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Book Description
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Author: Gloria Hall
Publisher:
ISBN: 9781947493797
Category :
Languages : en
Pages :
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Book Description
Author: Jack Wong
Publisher: CRC Press
ISBN: 0429996764
Category : Medical
Languages : en
Pages : 494
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Book Description
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 demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. 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. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.
