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Author: Charlene Cho
Publisher:
ISBN: 9781641059718
Category : Medical instruments and apparatus
Languages : en
Pages : 389
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Book Description
"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"--
Author: Charlene Cho
Publisher:
ISBN: 9781641059718
Category : Medical instruments and apparatus
Languages : en
Pages : 389
Get Book Here
Book Description
"Each chapter in this book describes the general concepts that frame a given subject area and addresses some of the basic administrative, regulatory, and compliance concerns that arise in the context of bringing a medical device to market"--
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225
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Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Michael Cheng
Publisher: World Health Organization
ISBN: 9241546182
Category : Medical
Languages : en
Pages : 54
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Book Description
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: Nitish V. Thakor
Publisher: Springer Nature
ISBN: 9811655405
Category : Technology & Engineering
Languages : en
Pages : 3686
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Book Description
This Handbook serves as an authoritative reference book in the field of Neuroengineering. Neuroengineering is a very exciting field that is rapidly getting established as core subject matter for research and education. The Neuroengineering field has also produced an impressive array of industry products and clinical applications. It also serves as a reference book for graduate students, research scholars and teachers. Selected sections or a compendium of chapters may be used as “reference book” for a one or two semester graduate course in Biomedical Engineering. Some academicians will construct a “textbook” out of selected sections or chapters. The Handbook is also meant as a state-of-the-art volume for researchers. Due to its comprehensive coverage, researchers in one field covered by a certain section of the Handbook would find other sections valuable sources of cross-reference for information and fertilization of interdisciplinary ideas. Industry researchers as well as clinicians using neurotechnologies will find the Handbook a single source for foundation and state-of-the-art applications in the field of Neuroengineering. Regulatory agencies, entrepreneurs, investors and legal experts can use the Handbook as a reference for their professional work as well.
Author: Jean-Pierre Boutrand
Publisher: Woodhead Publishing
ISBN: 0081026447
Category : Technology & Engineering
Languages : en
Pages : 592
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Book Description
Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. - Presents diverse insights from experts in government, industry and academia - Delivers a comprehensive overview of testing and interpreting medical device performance - Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market
Author: Pieter Kubben
Publisher: Springer
ISBN: 3319997130
Category : Medical
Languages : en
Pages : 219
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Book Description
This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.
Author: Nilanjan Dey
Publisher: Academic Press
ISBN: 012819362X
Category : Technology & Engineering
Languages : en
Pages : 324
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Book Description
Sensors for Health Monitoring discusses the characteristics of U-Healthcare systems in different domains, providing a foundation for working professionals and undergraduate and postgraduate students. The book provides information and advice on how to choose the best sensors for a U-Healthcare system, advises and guides readers on how to overcome challenges relating to data acquisition and signal processing, and presents comprehensive coverage of up-to-date requirements in hardware, communication and calculation for next-generation uHealth systems. It then compares new technological and technical trends and discusses how they address expected u-Health requirements. In addition, detailed information on system operations is presented and challenges in ubiquitous computing are highlighted. The book not only helps beginners with a holistic approach toward understanding u-Health systems, but also presents researchers with the technological trends and design challenges they may face when designing such systems. - Presents an outstanding update on the use of U-Health data analysis and management tools in different applications, highlighting sensor systems - Highlights Internet of Things enabled U-Healthcare - Covers different data transmission techniques, applications and challenges with extensive case studies for U-Healthcare systems
Author: Susan Neadle
Publisher: CRC Press
ISBN: 1000874583
Category : Medical
Languages : en
Pages : 439
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Book Description
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices. This handbook: Brings clarity of understanding for global combination products guidance and regulations Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market Reviews medical product classification and assignment issues faced by global regulatory authorities and industry The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Author: Josep Solà
Publisher: Springer Nature
ISBN: 3030247015
Category : Medical
Languages : en
Pages : 245
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Book Description
This book is the first comprehensive overview of the emerging field of cuffless blood pressure monitoring. Increasing clinical evidence proves that longitudinal measurements of blood pressure allow for earlier detection and better management of multiple medical conditions and for superior prediction of cardiovascular events. Unfortunately, today’s clinical and industry standards for blood pressure monitoring still require the inflation of a pneumatic cuff around a limb each time a measurement is taken. Over the last decades clinicians, scientists and device manufacturers have explored the feasibility of technologies that reduce or even completely eliminate the need of cuffs, initiating the era of cuffless blood pressure monitoring. Among the existing literature, this book is intended to be a practical guide to navigate across this emerging field. The chapters of the handbook have been elaborated by experts and key opinion leaders in the domain, and will guide the reader along the clinical, scientific, technical, and regulatory aspects of cuffless blood pressure monitoring.
Author: Adam Bohr
Publisher: Academic Press
ISBN: 0128184396
Category : Computers
Languages : en
Pages : 385
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Book Description
Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data
