Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products, Wong Jack, Tong Raymond K. Y.
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Название: Handbook of Medical Device Regulatory Affairs in Asia ISBN: 9814774316 ISBN-13(EAN): 9789814774314 Издательство: Taylor&Francis Цена: 17762.00 р. Наличие на складе: Есть у поставщикаПоставка под заказ. Описание: 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.
Автор: Kalet Ira J. Название: Principles of Biomedical Informatics, 2 ed ISBN: 0124160190 ISBN-13(EAN): 9780124160194 Издательство: Elsevier Science Рейтинг: Цена: 12462.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Provides a treatment of the deep computational ideas at the foundation of the field. This book includes exercises at the end of each chapter, ideas for student projects, and a number of new topics, such as: tree structured data, interval trees, and time-oriented medical data and their use.
Название: Handbook of Medical Device Regulatory Affairs in Asia ISBN: 9814774316 ISBN-13(EAN): 9789814774314 Издательство: Taylor&Francis Рейтинг: Цена: 17762.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 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.
Автор: Gad, Shayne Cox Gad-mcdonald, Samantha Название: Biomaterials, medical devices, and combination products ISBN: 1482248379 ISBN-13(EAN): 9781482248371 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Biomaterials, Medical Devices, and Combination Products is a single-volume guide for those responsible for--or concerned with--developing and ensuring patient safety in the use and manufacture of medical devices.
The book provides a clear presentation of the global regulatory requirements and challenges in evaluating the biocompatibility and clinical safety of the materials used in producing medical devices as well as the devices themselves.
Starting with material characterization and selection, considerations of concerns arising from packaging and contact with production machinery, and extensive coverage of combination products, the book also provides the latest approaches to isolating, quantitating, identifying and assessing the risk arising from chemical entities released from market-ready devices.
Also incorporated are new case examples and citations with the means of access to Internet-based regulatory and scientific sites, reflecting the universal adoption of this technology into our world.
The book takes into consideration the fact that device markets are global, the continual advancement of technology, and the increasing global harmonization of safety regulations. Each aspect of device safety evaluation is reviewed in terms of the International Organization for Standardization (ISO), US Food and Drug Administration (FDA), European Union (EU), and Japanese Ministry of Health, Labour, and Welfare (MHLW) perspectives.
Energy Efficiency of Medical Devices and Healthcare Facilities provides comprehensive coverage of cutting-edge, interdisciplinary research, and commercial solutions in this field. The authors discuss energy-related challenges, such as energy-efficient design, including renewable energy, of different medical devices from a hardware and mechanical perspectives, as well as energy management solutions and techniques in healthcare networks and facilities. They also discuss energy-related trade-offs to maximize the medical devices availability, especially battery-operated ones, while providing immediate response and low latency communication in emergency situations, sustainability and robustness for chronic disease treatment, in addition to high protection against cyber-attacks that may threaten patients' lives. Finally, the book examines technologies and future trends of next generation healthcare from an energy efficiency and management point of view, such as personalized or smart health and the Internet of Medical Things -- IoMT, where patients can participate in their own treatment through innovative medical devices and software applications and tools. The books applied approach makes it a useful resource for engineering researchers and practitioners of all levels involved in medical devices development, healthcare systems, and energy management of healthcare facilities. Graduate students in mechanical and electric engineering, and computer science students and professionals also benefit.
Автор: Furht Название: Handbook of Medical and Healthcare Technologies ISBN: 1461484944 ISBN-13(EAN): 9781461484943 Издательство: Springer Рейтинг: Цена: 23757.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The first part of the book presents medical technologies such as medical information retrieval, tissue engineering techniques, 3D medical imaging, nanotechnology innovations in medicine, medical wireless sensor networks, and knowledge mining techniques in medicine.
Автор: Borko Furht; Ankur Agarwal Название: Handbook of Medical and Healthcare Technologies ISBN: 149395301X ISBN-13(EAN): 9781493953011 Издательство: Springer Рейтинг: Цена: 18167.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The first part of the book presents medical technologies such as medical information retrieval, tissue engineering techniques, 3D medical imaging, nanotechnology innovations in medicine, medical wireless sensor networks, and knowledge mining techniques in medicine.
Автор: Fiedler, Beth Ann Название: Managing Medical Devices within a Regulatory Framework ISBN: 012804179X ISBN-13(EAN): 9780128041796 Издательство: Elsevier Science Рейтинг: Цена: 19707.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle.
This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements.
Описание: This book explores how human factors and ergonomic principles are currently transforming healthcare. It reports on the design of systems and devices to improve the quality, safety, efficiency and effectiveness of patient care, and discusses findings on improving organizational outcomes in the healthcare setting, as well as approaches to analyzing and modeling those work aspects that are unique to healthcare. Based on papers presented at the AHFE 2019 International Conference on Human Factors and Ergonomics in Healthcare and Medical Devices, held on July 24–28, 2019, in Washington, DC, USA, the book highlights the physical, cognitive and organizational aspects of human factors and ergonomic applications, and shares various perspectives, including those of clinicians, patients, health organizations, and insurance providers. Given its scope, the book offers a timely reference guide for researchers involved in the design of medical systems, and healthcare professionals managing healthcare settings, as well as healthcare counselors and international health organizations.
Описание: This book emphasizes the real-time challenges in medical modalities for variety of applications for analysis, classification and identification of different states for improvement of healthcare systems. Each chapter starts with the introduction, need and motivation of the medical modality and covers applications, alongwith real-time case studies.
Автор: Golombok Название: Regulating Reproductive Donation ISBN: 1107090962 ISBN-13(EAN): 9781107090965 Издательство: Cambridge Academ Рейтинг: Цена: 12197.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The emergence of new empirical evidence and ethical debate has called into question the current regulatory frameworks that govern reproductive donation, both in the UK and overseas. In response, this book offers fresh interdisciplinary perspectives on current challenges facing the regulation of reproductive donation, and suggests possible ways forward.
This book is concerned with human factors and ergonomics research and developments in the design and use of systems and devices for effective and safe healthcare delivery. It reports on approaches for improving healthcare devices so that they better fit to people's, including special population's needs. It also covers assistive devices aimed at reducing occupational risks of health professionals as well as innovative strategies for error reduction, and more effective training and education methods for healthcare workers and professionals. Equal emphasis is given to digital technologies and to physical, cognitive and organizational aspects, which are considered in an integrated manner, so as to facilitate a systemic approach for improving the quality and safety of healthcare service. The book also includes a special section dedicated to innovative strategies for assisting caregivers', patients', and people's needs during pandemic. Based on papers presented at the AHFE 2021 Conference on Human Factors and Ergonomics in Healthcare and Medical Devices, held virtually on 25-29 July, 2021, from USA, the book offers a timely reference guide to both researchers and healthcare professionals involved in the design of medical systems and managing healthcare settings, as well as to healthcare counselors and global health organizations.
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