Handbook of Medical Device Regulatory Affairs in Asia,
Новое издание
Автор: Wong Jack, Tong Raymond K. Y. Название: Medical Regulatory Affairs: An International Handbook for Medical Devices and Healthcare Products ISBN: 9814877867 ISBN-13(EAN): 9789814877862 Издательство: Taylor&Francis Цена: 29552.00 р. Наличие на складе: Есть у поставщикаПоставка под заказ. Описание: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application.
Автор: Kramme Название: Springer Handbook of Medical Technology ISBN: 3540746579 ISBN-13(EAN): 9783540746577 Издательство: Springer Рейтинг: Цена: 49631.00 р. Наличие на складе: Поставка под заказ.
Описание: This concise, user-oriented and up-to-date desk reference offers a broad introduction to the fascinating world of medical technology, fully considering today’s progress and further development in all relevant fields. The Springer Handbook of Medical Technology is a systemized and well-structured guideline which distinguishes itself through simplification and condensation of complex facts. This book is an indispensable resource for professionals working directly or indirectly with medical systems and appliances every day. It is also meant for graduate and post graduate students in hospital management, medical engineering, and medical physics.
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: KUCKLICK Название: The Medical Device R&D Handbook, Second Edition ISBN: 143981189X ISBN-13(EAN): 9781439811894 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving.The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies—both what works and what doesn’t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.
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: Mary Beth Privitera Название: Contextual Inquiry for Medical Device Design ISBN: 0128018526 ISBN-13(EAN): 9780128018521 Издательство: Elsevier Science Рейтинг: Цена: 15662.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance.
The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices.
Автор: Gail Baura Название: Medical Device Technologies, ISBN: 012374976X ISBN-13(EAN): 9780123749765 Издательство: Elsevier Science Рейтинг: Цена: 11488.00 р. Наличие на складе: Поставка под заказ.
Описание: Provides undergraduate engineering students with an introduction to commonly manufactured medical devices. This title discusses both electrical and mechanical medical devices.
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.
Автор: Privitera, Mary Beth Название: Applied Human Factors in Medical Device Design ISBN: 0128161639 ISBN-13(EAN): 9780128161630 Издательство: Elsevier Science Рейтинг: Цена: 19875.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in depth descriptions of both empirical and analytical methodology. The book aims to improve the ability of designers and auditors to determine the safety and efficacy of a product through the use of design controls and methods. It begins with an overview of the design control process integrating human factors as directed by AAMI TIR 59 and experienced practice. It then goes on to explain each method and describes, in detail, why each method is important, the potential impact, when it is ideal to use or not use, and challenges that may occur. Also discussed are the challenges wherein barriers, such as communication breakdowns between users and design teams hindered integrating human factors in medical device design.
Applied Human Factors in Medical Device Design is an excellent reference for Medical device industry professionals in human factors, design, engineering, marketing and regulatory.
Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU).
Explains technology development and the application of human factors throughout the development process in consideration of the healthcare environment.
Covers FDA and MHRA regulations.
Case examples included with each method.
Автор: Wiklund, Michael E., P.e. Dwyer, Andrea M. Davis, Erin Название: Medical device use error ISBN: 1498705790 ISBN-13(EAN): 9781498705790 Издательство: Taylor&Francis Рейтинг: Цена: 22968.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Medical Device Use Error: Root Cause Analysis offers practical guidance on how to methodically discover and explain the root cause of a use error--a mistake--that occurs when someone uses a medical device. Covering medical devices used in the home and those used in clinical environments, the book presents informative case studies about the use errors (mistakes) that people make when using a medical device, the potential consequences, and design-based preventions.
Using clear illustrations and simple narrative explanations, the text:
Covers the fundamentals and language of root cause analysis and regulators' expectations regarding the thorough analysis of use errors
Describes how to identify use errors, interview users about use errors, and fix user interface design flaws that could induce use errors
Reinforces the application of best practices in human factors engineering, including conducting both formative and summative usability tests
Medical Device Use Error: Root Cause Analysis delineates a systematic method of analyzing medical device use errors. The book provides a valuable reference to human factors specialists, product development professionals, and others committed to making medical devices as safe and effective as possible.
ООО "Логосфера " Тел:+7(495) 980-12-10 www.logobook.ru
