International Labeling Requirements For Medical Devices Medical Equipment And Diagnostic Products

Author : Charles Sidebottom
Publisher : CRC Press
Page : 616 pages
File Size : 52,7 Mb
Release : 2019-08-30
Category : Electronic
ISBN : 0367395169

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International Labeling Requirements for Medical Devices, Medical Equipment and Diagnostic Products by Charles Sidebottom Pdf

Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.

Author : Charles B. Sidebottom
Publisher : Interpharm Press
Page : 498 pages
File Size : 48,8 Mb
Release : 1995-05-01
Category : Medical
ISBN : 0935184716

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International Labeling Requirements for Medical Devices, Medical Equipment, and Diagnostic Products by Charles B. Sidebottom Pdf

Author : Jack Wong,Raymond K. Y. Tong
Publisher : CRC Press
Page : 620 pages
File Size : 46,5 Mb
Release : 2022-01-27
Category : Medical
ISBN : 9781000440539

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Medical Regulatory Affairs by Jack Wong,Raymond K. Y. Tong Pdf

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.

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 55,8 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

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 : Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić
Publisher : Springer Nature
Page : 441 pages
File Size : 44,7 Mb
Release : 2023-12-28
Category : Technology & Engineering
ISBN : 9783031434440

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Inspection of Medical Devices by Almir Badnjević,Mario Cifrek,Ratko Magjarević,Zijad Džemić Pdf

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 : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 40,6 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Author : United States. Bureau of Medical Devices
Publisher : Unknown
Page : 240 pages
File Size : 46,9 Mb
Release : 1977
Category : Medical instruments and apparatus
ISBN : CHI:72914235

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Bureau of Medical Devices Standards Survey by United States. Bureau of Medical Devices Pdf

Author : British Standards Institute Staff
Publisher : Unknown
Page : 62 pages
File Size : 53,9 Mb
Release : 1911-10-31
Category : Electronic
ISBN : 0580773272

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In Vitro Diagnostic Medical Devices. Information Supplied by the Manufacturer (Labelling). Terms, Definitions and General Requirements by British Standards Institute Staff Pdf

Diagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Clinical investigation instruments, Diagnostic reagents, Clinical laboratory equipment, Reagent solutions, Definitions, Measurement

Author : Jack Wong,Raymond Tong
Publisher : CRC Press
Page : 620 pages
File Size : 41,9 Mb
Release : 2018-03-28
Category : Medical
ISBN : 9780429996771

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Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong,Raymond Tong Pdf

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.

Author : Anonim
Publisher : Academic Press
Page : 369 pages
File Size : 49,5 Mb
Release : 2012-12-17
Category : Technology & Engineering
ISBN : 9780123919434

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Medical Device Design by Anonim Pdf

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

Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Page : 256 pages
File Size : 46,6 Mb
Release : 2015-08-18
Category : Medical
ISBN : 9780081002919

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Medical Devices by Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo Pdf

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

Author : Jack Wong,Raymond Tong Kaiyu
Publisher : CRC Press
Page : 618 pages
File Size : 48,9 Mb
Release : 2013-03-27
Category : Medical
ISBN : 9789814411219

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Handbook of Medical Device Regulatory Affairs in Asia by Jack Wong,Raymond Tong Kaiyu Pdf

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.

Author : Amiram Daniel
Publisher : Quality Press
Page : 355 pages
File Size : 50,7 Mb
Release : 2008-01-01
Category : Medical
ISBN : 9780873897402

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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by Amiram Daniel Pdf

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 : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 318 pages
File Size : 52,6 Mb
Release : 2011-10-25
Category : Medical
ISBN : 9780309212458

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Medical Devices and the Public's Health by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Author : World Health Organization
Publisher : World Health Organization
Page : 147 pages
File Size : 47,8 Mb
Release : 2010
Category : Medical
ISBN : 9789241564045

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Medical Devices by World Health Organization Pdf

Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9