Author:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 396

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Book Description

Author: Rommel Garcia
Publisher: Xlibris Corporation
ISBN: 1524589209
Category : Medical
Languages : en
Pages : 403

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Book Description
This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.

Author: British Standards Institute Staff
Publisher:
ISBN: 9780580340574
Category :
Languages : en
Pages : 40

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Book Description
Medical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Patient monitors, Clinical investigation instruments, Monitors, Pressure, Skin (body), Transducers, Oxygen, Carbon dioxide, Pressure measurement (fluids), Electrical safety, Safety, Performance, Performance testing

Author: David J. Reinkensmeyer
Publisher: Springer
ISBN: 331928603X
Category : Medical
Languages : en
Pages : 647

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Book Description
This revised, updated second edition provides an accessible, practical overview of major areas of technical development and clinical application in the field of neurorehabilitation movement therapy. The initial section provides a rationale for technology application in movement therapy by summarizing recent findings in neuroplasticity and motor learning. The following section then explains the state of the art in human-machine interaction requirements for clinical rehabilitation practice. Subsequent sections describe the ongoing revolution in robotic therapy for upper extremity movement and for walking, and then describe other emerging technologies including electrical stimulation, virtual reality, wearable sensors, and brain-computer interfaces. The promises and limitations of these technologies in neurorehabilitation are discussed. Throughout the book the chapters provide detailed practical information on state-of-the-art clinical applications of these devices following stroke, spinal cord injury, and other neurologic disorders. The text is illustrated throughout with photographs and schematic diagrams which serve to clarify the information for the reader. Neurorehabilitation Technology, Second Edition is a valuable resource for neurologists, biomedical engineers, roboticists, rehabilitation specialists, physiotherapists, occupational therapists and those training in these fields.

Author:
Publisher:
ISBN:
Category : Medical care
Languages : en
Pages : 1896

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Book Description

Author: Richard C. Fries
Publisher: CRC Press
ISBN: 1439894949
Category : Medical
Languages : en
Pages : 501

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Book Description
As medical devices become even more intricate, concerns about efficacy, safety, and reliability continue to be raised. Users and patients both want the device to operate as specified, perform in a safe manner, and continue to perform over a long period of time without failure. Following in the footsteps of the bestselling second edition, Reliable D

Author: Suzanne M. Burns
Publisher: Jones & Bartlett Learning
ISBN: 9780763738259
Category : Medical
Languages : en
Pages : 134

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Book Description
This Protocol delineates the evidence for using devices for noninvasive patient monitoring of blood pressure, heart rhythms, pulse oximetry, end-tidal carbon dioxide, and respiratory waveforms. These protocols guide clinicians in the appropriate selection of patients for use of the device, application of the device, initial and ongoing monitoring, device removal, and selected aspects of quality control.

Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 638

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Book Description

Author: Peter Luppa
Publisher: Springer
ISBN: 3662544970
Category : Medical
Languages : en
Pages : 451

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Book Description
The underlying technology and the range of test parameters available are evolving rapidly. The primary advantage of POCT is the convenience of performing the test close to the patient and the speed at which test results can be obtained, compared to sending a sample to a laboratory and waiting for results to be returned. Thus, a series of clinical applications are possible that can shorten the time for clinical decision-making about additional testing or therapy, as delays are no longer caused by preparation of clinical samples, transport, and central laboratory analysis. Tests in a POC format can now be found for many medical disciplines including endocrinology/diabetes, cardiology, nephrology, critical care, fertility, hematology/coagulation, infectious disease and microbiology, and general health screening. Point-of-care testing (POCT) enables health care personnel to perform clinical laboratory testing near the patient. The idea of conventional and POCT laboratory services presiding within a hospital seems contradictory; yet, they are, in fact, complementary: together POCT and central laboratory are important for the optimal functioning of diagnostic processes. They complement each other, provided that a dedicated POCT coordination integrates the quality assurance of POCT into the overall quality management system of the central laboratory. The motivation of the third edition of the POCT book from Luppa/Junker, which is now also available in English, is to explore and describe clinically relevant analytical techniques, organizational concepts for application and future perspectives of POCT. From descriptions of the opportunities that POCT can provide to the limitations that clinician’s must be cautioned about, this book provides an overview of the many aspects that challenge those who choose to implement POCT. Technologies, clinical applications, networking issues and quality regulations are described as well as a survey of future technologies that are on the future horizon. The editors have spent considerable efforts to update the book in general and to highlight the latest developments, e.g., novel POCT applications of nucleic acid testing for the rapid identification of infectious agents. Of particular note is also that a cross-country comparison of POCT quality rules is being described by a team of international experts in this field.

Author: National Research Council
Publisher: National Academies Press
ISBN: 0309154006
Category : Science
Languages : en
Pages : 246

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Book Description
A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.