Class 1 Devices Book

Class 1 Devices


  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release Date : 2014-11-24
  • Genre: Technology & Engineering
  • Pages : 114
  • ISBN 10 : 9780128007969

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Class 1 Devices Excerpt :

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.

Hearing Health Care for Adults Book

Hearing Health Care for Adults


  • Author : National Academies of Sciences, Engineering, and Medicine
  • Publisher : National Academies Press
  • Release Date : 2016-10-06
  • Genre: Medical
  • Pages : 324
  • ISBN 10 : 9780309439268

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Hearing Health Care for Adults Excerpt :

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 Book

Medical Devices


  • Author : United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment
  • Publisher : Unknown
  • Release Date : 1974
  • Genre: Medical instruments and apparatus
  • Pages : 446
  • ISBN 10 : LOC:0018385320A

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Medical Devices Excerpt :

Medical Device Design Book

Medical Device Design


  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release Date : 2012-12-17
  • Genre: Technology & Engineering
  • Pages : 376
  • ISBN 10 : 9780123919434

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Medical Device Design Excerpt :

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

Medical Device Regulations Book

Medical Device Regulations


  • Author : Aakash Deep
  • Publisher : Academic Press
  • Release Date : 2022-01-13
  • Genre: Technology & Engineering
  • Pages : 186
  • ISBN 10 : 9780323911276

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Medical Device Regulations Excerpt :

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

Medical Devices Book

Medical Devices


  • Author : United States. Food and Drug Administration
  • Publisher : Unknown
  • Release Date : 2022-07-05
  • Genre: Medical instruments and apparatus
  • Pages : null
  • ISBN 10 : MINN:30000010715898

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Medical Devices Excerpt :

BIOMEDICAL DEVICE TECHNOLOGY Book

BIOMEDICAL DEVICE TECHNOLOGY


  • Author : Anthony Y. K. Chan
  • Publisher : Charles C Thomas Publisher
  • Release Date : 2016-03-28
  • Genre: Biomedical engineering
  • Pages : 788
  • ISBN 10 : 9780398090838

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BIOMEDICAL DEVICE TECHNOLOGY Excerpt :

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 Devices and the Public s Health Book

Medical Devices and the Public s Health


  • Author : Institute of Medicine
  • Publisher : National Academies Press
  • Release Date : 2011-10-25
  • Genre: Medical
  • Pages : 318
  • ISBN 10 : 9780309212458

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Medical Devices and the Public s Health Excerpt :

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.

Winn L  Rosch Hardware Bible Book

Winn L Rosch Hardware Bible


  • Author : Winn L. Rosch
  • Publisher : Que Publishing
  • Release Date : 2003
  • Genre: Computers
  • Pages : 1128
  • ISBN 10 : 0789728591

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Winn L Rosch Hardware Bible Excerpt :

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.

Biomaterials  Artificial Organs and Tissue Engineering Book

Biomaterials Artificial Organs and Tissue Engineering


  • Author : L Hench
  • Publisher : Elsevier
  • Release Date : 2005-09-27
  • Genre: Science
  • Pages : 304
  • ISBN 10 : 9781845690861

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Biomaterials Artificial Organs and Tissue Engineering Excerpt :

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 Book

The Impact of Academic Research on Industrial Performance


  • Author : National Academy of Engineering
  • Publisher : National Academies Press
  • Release Date : 2003-10-06
  • Genre: Political Science
  • Pages : 264
  • ISBN 10 : 0309166969

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The Impact of Academic Research on Industrial Performance Excerpt :

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.

Class 2 Devices Book

Class 2 Devices


  • Author : Peter J. Ogrodnik
  • Publisher : Unknown
  • Release Date : 2015-03-01
  • Genre: Medical
  • Pages : 50
  • ISBN 10 : 0128000279

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Class 2 Devices Excerpt :

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.

Natural Based Polymers for Biomedical Applications Book

Natural Based Polymers for Biomedical Applications


  • Author : Tatiana G. Volova
  • Publisher : CRC Press
  • Release Date : 2017-04-21
  • Genre: Medical
  • Pages : 440
  • ISBN 10 : 9781315341811

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Natural Based Polymers for Biomedical Applications Excerpt :

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.