Medical Devices

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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!

Handbook Of Medical Device Regulatory Affairs In Asia

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Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2013-03-27

Handbook Of Medical Device Regulatory Affairs In Asia written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-03-27 with Medical categories.

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. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Medical Devices

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Author : Seeram Ramakrishna
language : en
Publisher: Woodhead Publishing
Release Date : 2015-08-18

Medical Devices written by Seeram Ramakrishna and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-18 with Medical categories.

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. - Provides readers with a global perspective on medical device regulations - Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards - Includes a useful case study demonstrating the design and approval process

Medical Device Regulations

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Author : Michael Cheng
language : en
Publisher: Diamond Pocket Books (P) Ltd.
Release Date : 2003-09-16

Medical Device Regulations written by Michael Cheng and has been published by Diamond Pocket Books (P) Ltd. 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.

Encyclopedia Of Medical Devices And Instrumentation

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Author : John G. Webster
language : en
Publisher: Wiley-Interscience
Release Date : 2006-04-07

Encyclopedia Of Medical Devices And Instrumentation written by John G. Webster and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-04-07 with Medical categories.

The articles in The Encyclopedia of Medical Devices and Instrumentation focus on what is currently useful or is likely to be useful in future medicine. They answer the question, What are the branches of medicine and how does technology assist each of them? Articles focus on the practice of medicine that is assisted by devices, rather than including, for example, the use of drugs to treat disease. The title is the only resource on the market dealing with the subject in encyclopedic detail. * Accessible to practitioners with a broad range of backgrounds from students to researchers and physicians * Articles cover the latest developments such as nanotechnology, fiber optics, and signal processing

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 Regulatory Affairs

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Author : Jack Wong
language : en
Publisher: CRC Press
Release Date : 2022-01-26

Medical Regulatory Affairs written by Jack Wong and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-26 with Medical categories.

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. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.

Medical Devices Abbreviations Acronyms And Eponyms

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Author : Tim B. Hunter
language : en
Publisher: Mosby Elsevier Health Science
Release Date : 1994

Medical Devices Abbreviations Acronyms And Eponyms written by Tim B. Hunter and has been published by Mosby Elsevier Health Science this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Medical categories.

Medical Device Design

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Author :
language : en
Publisher: Academic Press
Release Date : 2012-12-17

Medical Device Design written by and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-17 with Technology & Engineering categories.

This book provides the bridge between engineering design and medical device development. There is no single text that addresses the plethora of design issues a medical devices designer meets when developing new products or improving older ones. It addresses medical devices' regulatory (FDA and EU) requirements--some of the most stringent engineering requirements globally. Engineers failing to meet these requirements can cause serious harm to users as well as their products’ commercial prospects. This Handbook shows the essential methodologies medical designers must understand to ensure their products meet requirements. It brings together proven design protocols and puts them in an explicit medical context based on the author's years of academia (R&D phase) and industrial (commercialization phase) experience. This design methodology enables engineers and medical device manufacturers to bring new products to the marketplace rapidly. The medical device market is a multi-billion dollar industry. Every engineered product for this sector, from scalpelsstents to complex medical equipment, must be designed and developed to approved procedures and standards. This book shows how Covers US, and EU and ISO standards, enabling a truly international approach, providing a guide to the international standards that practicing engineers require to understand Written by an experienced medical device engineers and entrepreneurs with products in the from the US and UK and with real world experience of developing and commercializing medical products

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.