Developing Biomedical Devices
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Developing Biomedical Devices
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Author : Giuseppe Andreoni
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-09-24
Developing Biomedical Devices written by Giuseppe Andreoni and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-09-24 with Technology & Engineering categories.
During the past two decades incredible progress has been achieved in the instruments and devices used in the biomedical field. This progress stems from continuous scientific research that has taken advantage of many findings and advances in technology made available by universities and industry. Innovation is the key word and in this context legal protection and intellectual property rights (IPR) are of crucial importance. This book provides students and practitioners with the fundamentals for designing biomedical devices and explains basic design principles. Furthermore, as an aid to the development of devices and products for healthcare, it presents a brief description of the human body, covering anatomy and physiology, that will assist the reader in understanding the origin of biosignals, their significance and the technology to be used in their measurement. Issues concerning IPR and protections are also fully discussed, with examples and opportunities for IPR exploitation.
Medical Device Design
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Author :
language : en
Publisher: Academic Press
Release Date : 2012-12-17
Medical Device Design written by and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-17 with Technology & Engineering categories.
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
New Medical Devices
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1988-02-01
New Medical Devices written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1988-02-01 with Medical categories.
In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
Trends In Development Of Medical Devices
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Author : Prakash Srinivasan Timiri Shanmugam
language : en
Publisher: Academic Press
Release Date : 2020-01-25
Trends In Development Of Medical Devices written by Prakash Srinivasan Timiri Shanmugam and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-01-25 with Technology & Engineering categories.
Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities
Medical Instrument Design And Development
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Author : Claudio Becchetti
language : en
Publisher: John Wiley & Sons
Release Date : 2013-05-20
Medical Instrument Design And Development written by Claudio Becchetti and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-05-20 with Science categories.
This book explains all of the stages involved in developingmedical devices; from concept to medical approval including systemengineering, bioinstrumentation design, signal processing,electronics, software and ICT with Cloud and e-Healthdevelopment. Medical Instrument Design and Development offers a comprehensivetheoretical background with extensive use of diagrams, graphics andtables (around 400 throughout the book). The book explains how thetheory is translated into industrial medical products using amarket-sold Electrocardiograph disclosed in its design by the GammaCardio Soft manufacturer. The sequence of the chapters reflects the product developmentlifecycle. Each chapter is focused on a specific University courseand is divided into two sections: theory and implementation. Thetheory sections explain the main concepts and principles whichremain valid across technological evolutions of medicalinstrumentation. The Implementation sections show how the theory istranslated into a medical product. The Electrocardiograph(ECG or EKG) is used as an example as it is a suitable device toexplore to fully understand medical instrumentation since it issufficiently simple but encompasses all the main areas involved indeveloping medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing,information theory, electronics, software, firmware, telemedicine,e-Health and medical device certification Explains how to use theory to implement a market product (usingECG as an example) Examines the design and applications of main medicalinstruments Details the additional know-how required for productimplementation: business context, system design, projectmanagement, intellectual property rights, product life cycle,etc. Includes an accompanying website with the design of thecertified ECG product (ahref="http://www.gammacardiosoft.it/book"www.gammacardiosoft.it/book/a) Discloses the details of a marketed ECG Product (from GammaCardio Soft) compliant with the ANSI standard AAMI EC 11under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses(upper-level undergraduate and graduate students) and for engineersinterested in medical instrumentation/device design with acomprehensive and interdisciplinary system perspective.
Medical Devices
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Author : Seeram Ramakrishna
language : en
Publisher: Woodhead Publishing
Release Date : 2015-08-18
Medical Devices written by Seeram Ramakrishna and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-08-18 with Medical categories.
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
Biomedical Devices
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Author : Raymond H. W. Lam
language : en
Publisher: Springer
Release Date : 2019-08-16
Biomedical Devices written by Raymond H. W. Lam and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-16 with Medical categories.
This textbook provides essential knowledge for biomedical product development, including material properties, fabrication processes and design techniques for different applications, as well as process design and optimization. This book is multidisciplinary and readers can learn techniques to apply acquired knowledge for various applications of biomedical design. Further, this book encourages readers to discover and convert newly reported technologies into products and services for the future development of biomedical applications. This is an ideal book for upper-level undergraduate and graduate students, engineers, technologists, and researchers working in the area of biomedical engineering and manufacturing. This book also: Provides a comprehensive set of fundamental knowledge for engineering students and entry level engineers to design biomedical devices Offers a unique approach to manufacturing of biomedical devices by integrating and formulating different considerations in process design tasks into optimization problems Provides a broad range of application examples to guide readers through the thinking process of designing and manufacturing biomedical devices, from basic understanding about the requirements and regulations to a set of manufacturing parameters
Technological Innovation
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Author : Annetine C. Gelijns
language : en
Publisher: National Academies
Release Date : 1989
Technological Innovation written by Annetine C. Gelijns and has been published by National Academies this book supported file pdf, txt, epub, kindle and other format this book has been release on 1989 with Clinical medicine categories.
Development Of Medical Device Policies
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Author : World Health Organization
language : en
Publisher:
Release Date : 2012-10-25
Development Of Medical Device Policies written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-25 with Medical categories.
WHO and partners have been working towards devising an agenda, an action plan, tools and guidelines to increase access to appropriate medical devices. This document is part of a series of reference documents being developed for use at the country level. The series will include the following subject areas: * policy framework for health technology * medical device regulations * health technology assessment * health technology management * needs assessment of medical devices * medical device procurement * medical equipment donations * medical equipment inventory management * medical equipment maintenance * computerized maintenance management systems * medical device data * medical device nomenclature * medical devices by health-care setting * medical devices by clinical procedures * medical device innovation, research and development. These documents are intended for use by biomedical engineers, health managers, donors, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional or global levels. The number of countries with existing health technology policies and with units to implement those policies shows that there is forward movement in the development and implementation of health technology policies. However, because medical devices are complex to select, manage and use, it is important to ensure that new policies are developed appropriately and existing ones are modified as necessary to make them as effective as possible. Proper integration of health technology policies and strategies within the framework of a national health plan has the potential to harness the political support to ensure improved access, quality and use of medical devices, enhance the best use of the resources in a framework of universal coverage, respond to the needs of the population, and ultimately achieve better health outcomes.
Methods In Research And Development Of Biomedical Devices
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Author : Kelvin K. L. Wong
language : en
Publisher: World Scientific
Release Date : 2013
Methods In Research And Development Of Biomedical Devices written by Kelvin K. L. Wong and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Technology & Engineering categories.
This book presents a road map for applying the stages in conceptualization, evaluation, and testing of biomedical devices in a systematic order of approach, leading to solutions for medical problems within a well-deserved safety limit. The issues discussed will pave the way for understanding the preliminary concepts used in modern biomedical device engineering, which include medical imaging, computational fluid dynamics, finite element analysis, particle image velocimetry, and rapid prototyping. This book would undoubtedly be of use to biomedical engineers, medical doctors, radiologists, and any other professionals related to the research and development of devices for health care.
