Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2013-03-27 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 620 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Approval and Certification System Of East Asia written by Gyu Ha Ryu and published by DIYPIA. This book was released on 2016-12-16 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, even though a medical device industry has been grown rapidly as a next generation global industry, most of markets are dominated by some of major countries. A medical device is distinct from general goods; it requires not only ordinary medical engineering R&D knowledge, but also it involves with each phases of specific market knowledge, experience, and expertise from development to commercialization according to complicated regulatory affairs. Moreover, since the purpose of manufactured medical device is usually not only for domestic market but for overseas expansion, expertise of global medical device industry knowledge are needed, such as each country’s medical device law, data of medical device usage and etc… The book provides comprehensive, yet practical knowledge of product planning, research, development, manufacturing, certification and approval, and distribution of medical device in order to enable readers to conduction of business easily through general R&D education as well as essential subject, medical device approval and certification system. The main purpose of book is to foster practical medical device experts through understanding of medical device approval and certification system of East Asia including Korea, Japan, and China. Since the author has had an experienced working in Ministry of Food and Drug Safety (MFDS), especially in medical device certification department as well as an educator in Universities for a long time, the author contains practical-knowledge-oriented information such as problems and corresponding strategies of each country in an aspect of regulatory affairs based on 『global certification and approval for medical device』, which are distinct from a regular textbook: engineering-education-oriented information for medical device manufacturing. This book describes information of regulatory affairs easily for various class of readers: from a undergraduate and graduate student who are interested in medical device industry to personnel who are performing medical device regulation related work. The contained information is based on public announced material from each country’s regulatory authority. However, the contained information may change in the future due to characteristics of regulatory affairs. Therefore, the author will continuously publish revised edition and respectfully accept requests for revision and improvement. 2016. December Gyu Ha Ryu, ph.D
Download or read book Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato and published by Elsevier. This book was released on 2014-10-27 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Medical Device Validation Handbook written by Robert Packard and published by . This book was released on 2015-04-05 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reference text on validation processes for manufacturing medical devices.
Download or read book Handbook of Medical Device Regulatory Affairs in Asia written by Jack Wong and published by CRC Press. This book was released on 2018-03-28 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Device Regulatory Practices written by Val Theisz and published by CRC Press. This book was released on 2015-08-03 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.
Download or read book Medical Devices written by Seeram Ramakrishna and published by Woodhead Publishing. This book was released on 2015-08-18 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Future of Pharmaceutical Product Development and Research written by and published by Academic Press. This book was released on 2020-08-19 with total page 976 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques
Download or read book Generating evidence for artificial intelligence based medical devices written by and published by World Health Organization. This book was released on 2021-11-18 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Humans and Devices in Medical Contexts written by Susanne Brucksch and published by Springer Nature. This book was released on 2021-06-19 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the ways in which socio-technical settings in medical contexts find varying articulations in a specific locale. Focusing on Japan, it consists of nine case studies on topics concerning: experiences with radiation in Hiroshima, Nagasaki, and Fukushima; patient security, end-of-life and high-tech medicine in hospitals; innovation and diffusion of medical technology; and the engineering and evaluating of novel devices in clinical trials. The individual chapters situate humans and devices in medical settings in their given semantic, pragmatic, institutional and historical context. A highly interdisciplinary approach offers deep insights beyond the manifold findings of each case study, thereby enriching academic discussions on socio-technical settings in medical contexts amongst affiliated disciplines. This volume will be of broad interest to scholars, practitioners, policy makers and students from various disciplines, including Science and Technology Studies (STS), medical humanities, social sciences, ethics and law, business and innovation studies, as well as biomedical engineering, medicine and public health.
Download or read book Framing Asian Studies written by Albert Tzeng and published by ISEAS-Yusof Ishak Institute. This book was released on 2018-01-12 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the interconnection between geopolitical context and the ways this context frames our knowledge about Asia, highlighting previously neglected cause–effect relations. It also examines how various knowledge institutions promote and shape Asian Studies. The authors seek to explain why Asian Studies and its subfields developed in the way they did, and what the implications of these transformations might be on intellectual and political understandings of Asia. The book not only builds on the current debates on the decolonization and de-imperialization of knowledge about Asia; it also proposes a more multifaceted view rather than just examining the impact of the West on the framing of Asian Studies.
Download or read book Medical Device Regulations written by Michael Cheng and published by World Health Organization. This book was released on 2003-09-16 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Human resources for medical devices the role of biomedical engineers written by World Health Organization and published by World Health Organization. This book was released on 2017-05-09 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication addresses the role of the biomedical engineer in the development, regulation, management, training, and use of medical devices. The first part of the book looks at the biomedical engineering profession globally as part of the health workforce: global numbers and statistics, professional classification, general education and training, professional associations, and the certification process. The second part addresses all of the different roles that the biomedical engineer can have in the life cycle of the technology, from research and development, and innovation, mainly undertaken in academia; the regulation of devices entering the market; and the assessment or evaluation in selecting and prioritizing medical devices (usually at national level); to the role they play in the management of devices from selection and procurement to safe use in healthcare facilities. The annexes present comprehensive information on academic programs, professional societies, and relevant WHO and UN documents related to human resources for health as well as the reclassification proposal for ILO. This publication can be used to encourage the availability, recognition, and increased participation of biomedical engineers as part of the health workforce, particularly following the recent adoption of the recommendations of the UN High-Level Commission on Health Employment and Economic Growth, the WHO Global Strategy on Human Resources for Health, and the establishment of national health workforce accounts. The document also supports the aim of reclassification of the role of the biomedical engineer as a specific engineer that supports the development, access, and use of medical devices within the national, regional, and global occupation classification system.
Download or read book Designing for Safe Use written by Michael Wiklund and published by CRC Press. This book was released on 2019-03-11 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: How do you prevent a critical care nurse from accidentally delivering a morphine overdose to an ill patient? Or ensure that people don't insert their arm into a hydraulic mulcher? And what about enabling trapped airline passengers to escape safely in an emergency? Product designers and engineers face myriad such questions every day. Failure to answer them correctly can result in product designs that lead to injury or even death due to use error. Historically, designers and engineers have searched for answers by sifting through complicated safety standards or obscure industry guidance documents. Designing for Safe Use is the first comprehensive source of safety-focused design principles for product developers working in any industry. Inside you’ll find 100 principles that help ensure safe interactions with products as varied as baby strollers, stepladders, chainsaws, automobiles, apps, medication packaging, and even airliners. You’ll discover how protective features such as blade guards, roll bars, confirmation screens, antimicrobial coatings, and functional groupings can protect against a wide range of dangerous hazards, including sharp edges that can lacerate, top-heavy items that can roll over and crush, fumes that can poison, and small parts that can pose a choking hazard. Special book features include: Concise, illustrated descriptions of design principles Sample product designs that illustrate the book’s guidelines and exemplify best practices Literature references for readers interested in learning more about specific hazards and protective measures Statistics on the number of injuries that have arisen in the past due to causes that might be eliminated by applying the principles in the book Despite its serious subject matter, the book’s friendly tone, surprising anecdotes, bold visuals, and occasional attempts at dry humor will keep you interested in the art and science of making products safer. Whether you read the book cover-to-cover or jump around, the book’s relatable and practical approach will help you learn a lot about making products safe. Designing for Safe Use is a primer that will spark in readers a strong appreciation for the need to design safety into products. This reference is for designers, engineers, and students who seek a broad knowledge of safe design solutions. .
