Medical Device Safety
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Medical Device Safety
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Author : G.R Higson
language : en
Publisher: CRC Press
Release Date : 2001-10-29
Medical Device Safety written by G.R Higson and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-10-29 with Medical categories.
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety examines the prospects for achieving global harmonization in medical device regulation and describes a possible future global system. Unresolved difficulties are discussed while solutions are proposed. An essential book for all those involved in health physics, en
Medical Device Regulations
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Author : Michael Cheng
language : en
Publisher: World Health Organization
Release Date : 2003-09-16
Medical Device Regulations written by Michael Cheng and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-16 with Medical categories.
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.
Medical Device Safety
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Author : United States. Congress. House. Committee on Government Reform
language : en
Publisher:
Release Date : 2006
Medical Device Safety written by United States. Congress. House. Committee on Government Reform and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Medical categories.
Medical Device Safety And Quality Standards Systems And Clinical Reliability
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Author : Sedra Alialsagher Mohammed, Sarah Saad Fakhri, Maryam Mohsin Hameed, Baraa Jamal Abdalrhman, Zainab Saad Hani
language : en
Publisher: Book Rivers
Release Date : 2025-07-12
Medical Device Safety And Quality Standards Systems And Clinical Reliability written by Sedra Alialsagher Mohammed, Sarah Saad Fakhri, Maryam Mohsin Hameed, Baraa Jamal Abdalrhman, Zainab Saad Hani and has been published by Book Rivers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-07-12 with Antiques & Collectibles categories.
H R 1346 The Medical Device Safety Act Of 2009
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Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
language : en
Publisher:
Release Date : 2011
H R 1346 The Medical Device Safety Act Of 2009 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with Medical instruments and apparatus categories.
Medical Device Safety Service
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Author :
language : en
Publisher:
Release Date : 1998
Medical Device Safety Service written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998 with Medical instruments and apparatus categories.
Documents, news items, etc. concerning the European Union's regulation of medical devices. The MDSS can serve as the European representative for companies manufacturing medical devices.
Inspection Of Medical Devices
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Author : Almir Badnjević
language : en
Publisher: Springer Nature
Release Date : 2023-11-26
Inspection Of Medical Devices written by Almir Badnjević and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-26 with Technology & Engineering categories.
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!
Medical Equipment Safety
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Author : Joint Commission on Accreditation of Healthcare Organizations
language : en
Publisher:
Release Date : 1993-06
Medical Equipment Safety written by Joint Commission on Accreditation of Healthcare Organizations and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1993-06 with categories.
Medical Devices
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Author : Bertil Jacobson
language : en
Publisher: Elsevier Health Sciences
Release Date : 2007-02-23
Medical Devices written by Bertil Jacobson and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-23 with Medical categories.
Patient safety is important to all health professionals, but fatal accidents occur with medical devices every year. This is the first book for people who use medical equipment, rather than for engineers or technicians. It will help personnel within healthcare to avoid accidents by bridging the gap between the design principles and the user. The book encourages safe use of a wide range of equipment, from simple thermometers and blood-pressure cuffs to complex equipment such as pacemakers, ventilators and patient monitors. Simple explanations of basic medical devices Case histories of real-life accidents to highlight risk areas Clear, attractive illustrations "Tips" boxes identify particular problems "Basic Facts" boxes supply fundamental information needed by all readers "Technology" boxes provide more-advanced explanations for interested or experienced readers
Pharmaceutical And Medical Device Safety
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Author : Sonia Macleod
language : en
Publisher:
Release Date : 2019
Pharmaceutical And Medical Device Safety written by Sonia Macleod and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019 with categories.
"This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control."--Bloomsbury Publishing.