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Author: International Organization for Standardization
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 57
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Book Description
Author: International Organization for Standardization
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 57
Get Book Here
Book Description
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 57
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Book Description
Author: Amiram Daniel
Publisher: Quality Press
ISBN: 0873897404
Category : Medical
Languages : en
Pages : 355
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Book Description
How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.
Author: Association for the Advancement of Medical Instrumentation
Publisher:
ISBN: 9781570202018
Category :
Languages : en
Pages :
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Book Description
Author: International Organization for Standardization
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 0
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Book Description
Author: Richard C. Fries
Publisher: CRC Press
ISBN: 148227003X
Category : Medical
Languages : en
Pages : 497
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Book Description
"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."
Author: Almir Badnjević
Publisher: Springer Nature
ISBN: 3031434447
Category : Technology & Engineering
Languages : en
Pages : 441
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Book Description
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 36
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Book Description
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580619915
Category :
Languages : en
Pages : 72
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Book Description
Medical equipment, Medical instruments, Medical technology, Quality management, Quality assurance systems, Acceptance (approval), Management
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.
