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Class 1 Devices

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Class 1 Devices

Class 1 Devices Book
Author : Peter J Ogrodnik
Publisher : Academic Press
Release : 2014-11-24
ISBN : 0128007966
Language : En, Es, Fr & De

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Book Description :

The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik’s Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes. Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products. Joins up theory and practice in an accessible style.

Technological Innovation

Technological Innovation Book
Author : Annetine C. Gelijns
Publisher : National Academies
Release : 1989
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Technological Innovation book written by Annetine C. Gelijns, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Medical Devices and the Public s Health

Medical Devices and the Public s Health Book
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Release : 2011-10-25
ISBN : 0309212456
Language : En, Es, Fr & De

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Book Description :

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Medical Devices

Medical Devices Book
Author : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment
Publisher : Unknown
Release : 1974
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Medical Devices book written by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Hearing Health Care for Adults

Hearing Health Care for Adults Book
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Accessible and Affordable Hearing Health Care for Adults
Publisher : National Academies Press
Release : 2016-09-06
ISBN : 0309439299
Language : En, Es, Fr & De

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Book Description :

The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages.

Medical Devices

Medical Devices Book
Author : United States. Food and Drug Administration
Publisher : Unknown
Release : 2022-12-07
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Medical Devices book written by United States. Food and Drug Administration, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

BIOMEDICAL DEVICE TECHNOLOGY

BIOMEDICAL DEVICE TECHNOLOGY Book
Author : Anthony Y. K. Chan
Publisher : Charles C Thomas Publisher
Release : 2016-03-28
ISBN : 0398090831
Language : En, Es, Fr & De

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Book Description :

This book provides a comprehensive approach to studying the principles and design of biomedical devices as well as their applications in medicine. It is written for engineers and technologists who are interested in understanding the principles, design and applications of medical device technology. The book is also intended to be used as a textbook or reference for biomedical device technology courses in universities and colleges. It focuses on the functions and principles of medical devices (which are the invariant components) and uses specific designs and constructions to illustrate the concepts where appropriate. This book selectively covers diagnostic and therapeutic devices that are either commonly used or that their principles and design represent typical applications of the technology. In this second edition, almost every chapter has been revised—some with minor updates and some with significant changes and additions. For those who would like to know more, a collection of relevant published papers and book references is added at the end of each chapter. Based on feedback, a section on “Common Problems and Hazards” has been included for each medical device. In addition, more information is provided on the indications of use and clinical applications. Two new areas of medical device technology have been added in the two new chapters on “Cardiopulmonary Bypass Units” and “Audiology Equipment.”

Medical Device Regulations

Medical Device Regulations Book
Author : Aakash Deep
Publisher : Academic Press
Release : 2022-01-13
ISBN : 0323911277
Language : En, Es, Fr & De

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Book Description :

Medical Device Regulations: A Complete Guide describes a brief review of various regulatory bodies of major developed and developing countries around the world. The book covers the registration procedures of medical devices for pharmaceutical regulatory organizations. Sections provide guidance on dealing with the ethical considerations of medical device development, compliance with patient confidentiality using information from medical devices, the interoperability between, and among devices outside of healthcare, and the dynamics of implementation of new devices to ensure patient safety. The author brings forth relevant issues, challenges and demonstrates how management can foster increased clinical and non-clinical relations to enhance patient outcomes and the bottom-line by demystifying the regulatory impact on operational requirements. Provides clear information on regulatory pathways for the design and commercialization of Medical Devices in different countries Explains the difference between standards and mandatory regulations for each region, along with discussions of regulations from USFDA (USA), CDSCO (India), EMEA (European Union), SFDA (China) and PMDA (Japan) Compiles regulations for medical devices and pharmaceuticals worldwide, helping readers create globally compliant products

Winn L Rosch Hardware Bible

Winn L  Rosch Hardware Bible Book
Author : Winn L. Rosch
Publisher : Que Publishing
Release : 2003
ISBN : 9780789728593
Language : En, Es, Fr & De

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Book Description :

Explores the potential of Pentium processors, the function of the motherboard, disk interfaces, safety issues, mass storage technology, display systems, parallel and infared ports, and audio technology.

Medical Device Design

Medical Device Design Book
Author : Peter J Ogrodnik
Publisher : Academic Press
Release : 2012-12-17
ISBN : 0123919436
Language : En, Es, Fr & De

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Book Description :

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

Specifications Tolerances and Other Technical Requirements for Weighing and Measuring Devices

Specifications  Tolerances  and Other Technical Requirements for Weighing and Measuring Devices Book
Author : National Conference on Weights and Measures
Publisher : Unknown
Release : 1979
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Specifications Tolerances and Other Technical Requirements for Weighing and Measuring Devices book written by National Conference on Weights and Measures, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Biomaterials Artificial Organs and Tissue Engineering

Biomaterials  Artificial Organs and Tissue Engineering Book
Author : L Hench,J. Jones
Publisher : Elsevier
Release : 2005-09-27
ISBN : 1845690869
Language : En, Es, Fr & De

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Book Description :

Maintaining quality of life in an ageing population is one of the great challenges of the 21st Century. This book summarises how this challenge is being met by multi-disciplinary developments of specialty biomaterials, devices, artificial organs and in-vitro growth of human cells as tissue engineered constructs. Biomaterials, Artificial Organs and Tissue Engineering is intended for use as a textbook in a one semester course for upper level BS, MS and Meng students. The 25 chapters are organized in five parts: Part one provides an introduction to living and man-made materials for the non-specialist; Part two is an overview of clinical applications of various biomaterials and devices; Part three summarises the bioengineering principles, materials and designs used in artificial organs; Part four presents the concepts, cell techniques, scaffold materials and applications of tissue engineering; Part five provides an overview of the complex socio-economic factors involved in technology based healthcare, including regulatory controls, technology transfer processes and ethical issues. Comprehensive introduction to living and man-made materials Looks at clinical applications of various biomaterials and devices Bioengineering principles, materials and designs used in artificial organs are summarised

The Impact of Academic Research on Industrial Performance

The Impact of Academic Research on Industrial Performance Book
Author : National Academy of Engineering,Committee on the Impact of Academic Research on Industrial Performance
Publisher : National Academies Press
Release : 2003-10-06
ISBN : 9780309166966
Language : En, Es, Fr & De

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Book Description :

Drawing on the findings of sector-specific workshops, e-mail surveys, research literature, expert testimony, and committee and panel members’ expertise, this National Academy of Engineering study assesses the qualitative impact of academic research on five industriesâ€"network systems and communications; medical devices and equipment; aerospace; transportation, distribution, and logistics services; and financial services. The book documents the range and significance of academic research contributions to the five industriesâ€"comparing the importance of different types of contributions, the multi- and interdisciplinary nature of these contributions, and the multiple vectors by which academic research is linked to each industry. The book calls for action to address six cross-cutting challenges to university-industry interactions: the growing disciplinary and time-horizon-related imbalances in federal R&D funding, barriers to university-industry interaction in service industries, the critical role of academic research in the advancement of information technology, the role of academic research in the regulation of industry, the impact of technology transfer activities on core university research and education missions, and the search for new pathways and mechanisms to enhance the contributions of academic research to industry. The book also includes findings and recommendations specific to each industry.

Natural Based Polymers for Biomedical Applications

Natural Based Polymers for Biomedical Applications Book
Author : Tatiana G. Volova,Yuri S. Vinnik,Ekaterina I. Shishatskaya,Nadejda M. Markelova,Gennady E. Zaikov
Publisher : CRC Press
Release : 2017-04-21
ISBN : 1315341816
Language : En, Es, Fr & De

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Book Description :

This new book presents the authors’ biomedical studies of natural degradable biopolymers (polyhydroxyalkanoates [PHAs]) and discusses the demand for medical-grade materials and modern trends, focusing on the present status and future potential of PHAs. The authors present and summarize their most important results and findings obtained during the last few years in experimental studies and clinical trials of PHAs at the Institute of Biophysics Siberian Branch of Russian Academy of Science.

Power System Modelling and Scripting

Power System Modelling and Scripting Book
Author : Federico Milano
Publisher : Springer Science & Business Media
Release : 2010-09-08
ISBN : 3642136699
Language : En, Es, Fr & De

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Book Description :

Power system modelling and scripting is a quite general and ambitious title. Of course, to embrace all existing aspects of power system modelling would lead to an encyclopedia and would be likely an impossible task. Thus, the book focuses on a subset of power system models based on the following assumptions: (i) devices are modelled as a set of nonlinear differential algebraic equations, (ii) all alternate-current devices are operating in three-phase balanced fundamental frequency, and (iii) the time frame of the dynamics of interest ranges from tenths to tens of seconds. These assumptions basically restrict the analysis to transient stability phenomena and generator controls. The modelling step is not self-sufficient. Mathematical models have to be translated into computer programming code in order to be analyzed, understood and “experienced”. It is an object of the book to provide a general framework for a power system analysis software tool and hints for filling up this framework with versatile programming code. This book is for all students and researchers that are looking for a quick reference on power system models or need some guidelines for starting the challenging adventure of writing their own code.

CompTIA A Certification All in One For Dummies

CompTIA A  Certification All in One For Dummies Book
Author : Glen E. Clarke,Edward Tetz,Timothy L. Warner
Publisher : John Wiley & Sons
Release : 2019-08-16
ISBN : 1119581095
Language : En, Es, Fr & De

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Book Description :

Fully updated to cover the 2019 exam release! CompTIA's A+ certification is an essential certification to building a successful IT career. Test takers must pass both 90-question exams to be certified, and this book—plus online test bank—will help you reach your certification goal. The 9 minibooks map to the exam's objectives, and include new content on Windows 10, Scripting, Linux, and mobile devices. You’ll learn about how computers work, networking, computer repair and troubleshooting, security, permissions, and customer service. You'll also find test-taking advice and a review of the types of questions you'll see on the exam. Use the online test bank to test your knowledge and prepare for the exam Get up to speed on operating system basics Find out how to manage the operating system Discover maintenance and troubleshooting tips Inside is all the knowledge you need to pass the new A+ exam!

Artificial Intelligence of Things for Smart Green Energy Management

Artificial Intelligence of Things for Smart Green Energy Management Book
Author : Sarah El Himer,Mariyam Ouaissa,Abdulrahman A. A. Emhemed,Mariya Ouaissa,Zakaria Boulouard
Publisher : Springer Nature
Release : 2022-07-25
ISBN : 3031048512
Language : En, Es, Fr & De

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Book Description :

This book is intended to assist in the development of smart and efficient green energy solutions. It introduces energy systems, power generation, and power demands which able to minimise generation costs, power loss or environmental effects. It proposes cutting-edge solutions and approaches based on recent technologies such as intelligent renewable energy systems (wind and solar). These solutions, applied to different sectors, can provide a solid basis for meeting the needs of both developed and developing countries. The book provides a collection of contributions including new techniques, methods, algorithms, practical solutions and models based on applying artificial intelligence and the Internet of things into green energy management systems. It provides a comprehensive reference for researchers, scholars and industry in the field of green energy and computational intelligence.

Toxicological Aspects of Medical Device Implants

Toxicological Aspects of Medical Device Implants Book
Author : Prakash Srinivasan Timiri Shanmugam,Logesh Chokkalingam,Pramila Bakthavachalam
Publisher : Academic Press
Release : 2020-06-10
ISBN : 0128209208
Language : En, Es, Fr & De

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Book Description :

Toxicological Aspects of Medical Device Implants provides comprehensive information on the use of medical implant and devices and the balance between the application of the devices in relation to any potential adverse effects. In order to ensure the safety and effectiveness of medical devices, many international policies, regulations, and standards have been established, and the book also discusses medical devices within this regulatory framework. The book covers a broad range of disease topics and disease-specific implants and an interdisciplinary team of experts brings a wealth of information on implants used in various disease models and associated risk factors. Toxicological Aspects of Medical Device Implants is a comprehensive resource for toxicologists, biomedical engineers, immunologists, medical staff, regulators, and manufacturers working in the field who need to be aware of the potential toxicity and device management of such a wide variety of implants and devices and their health risks. Discusses the adverse toxicological effects of medical devices Covers a broad range of disease topics and disease specific implants Offers contributions from experts from across several disciplines