Medical Instrument Design And Development
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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.
Design And Development Of Medical Electronic Instrumentation
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Author : David Prutchi
language : en
Publisher: John Wiley & Sons
Release Date : 2005-01-28
Design And Development Of Medical Electronic Instrumentation written by David Prutchi 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 2005-01-28 with Technology & Engineering categories.
Design and Development of Medical Electronic Instrumentation fills a gap in the existing medical electronic devices literature by providing background and examples of how medical instrumentation is actually designed and tested. The book includes practical examples and projects, including working schematics, ranging in difficulty from simple biopotential amplifiers to computer-controlled defibrillators. Covering every stage of the development process, the book provides complete coverage of the practical aspects of amplifying, processing, simulating and evoking biopotentials. In addition, two chapters address the issue of safety in the development of electronic medical devices, and providing valuable insider advice.
Handbook Of Medical Device Design
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Author : Richard C. Fries
language : en
Publisher: CRC Press
Release Date : 2000-09-14
Handbook Of Medical Device Design written by Richard C. Fries and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-09-14 with Medical categories.
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
Medical Device Regulations
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Author : Michael Cheng
language : en
Publisher: World Health Organization
Release Date : 2003-09-16
Medical Device Regulations written by Michael Cheng and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-09-16 with Medical categories.
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.
Medical Instruments And Devices
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Author : Steven Schreiner
language : en
Publisher: CRC Press
Release Date : 2015-07-24
Medical Instruments And Devices written by Steven Schreiner and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-24 with Medical categories.
Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. It includes instruments and devices that span a range of physiological systems and the physiological scale: molecular, cellular, organ, and system. The book chronicles the evolution of pacemakers and their system operation and discusses oscillometry, cardiac output measurement, and the direct and indirect methods of measuring cardiac output. The authors also expound on the mechanics and safety of defibrillators and cover implantable stimulators, respiration, and the structure and function of mechanical ventilators. In addition, this text covers in depth: Anesthesia Delivery Electrosurgical Units and Devices Biomedical Lasers Measuring Cellular Traction Forces Blood Glucose Monitoring Atomic Force Microscopy Parenteral Infusion Devices Clinical Laboratory: Separation and Spectral Methods Clinical Laboratory: Nonspectral Methods and Automation Noninvasive Optical Monitoring An offshoot from the definitive bible of biomedical engineering, Medical Instruments and Devices: Principles and Practices offers you state-of-the-art information on biomedical instruments and devices. This text serves practicing professionals working in the areas of medical devices and instrumentation as well as graduate students studying bioengineering, instrumentation, and medical devices, and it provides readers with a practical foundation and a wealth of resources from well-known experts in the field.
The Changing Economics Of Medical Technology
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 1991-02-01
The Changing Economics Of Medical Technology 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 1991-02-01 with Medical categories.
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.
Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03
Rare Diseases And Orphan Products 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 2011-04-03 with Medical categories.
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Medical Device Design And Regulation
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Author : Carl T. DeMarco
language : en
Publisher: Quality Press
Release Date : 2011-01-24
Medical Device Design And Regulation written by Carl T. DeMarco and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-01-24 with Medical categories.
The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use or for employee training. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the “MDDR Users Group” on LinkedIn.
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices
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Author : World Health Organization
language : en
Publisher:
Release Date : 2017-05-09
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices 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 2017-05-09 with Law categories.
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.
Medical Device And Equipment Design
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Author : Michael E. Wiklund
language : en
Publisher: CRC Press
Release Date : 2024-11-01
Medical Device And Equipment Design written by Michael E. Wiklund and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-01 with Technology & Engineering categories.
The key to profitability and success in both the medical device and the equipment markets often relates to how easy your products are to use. User acceptance and preference frequently is dependent upon ergonomic design. Medical Device and Equipment Design helps you enhance your product design, maximize user acceptance, and minimize potential problems in the marketplace. It provides practical guidance on how to plan and incorporate ergonomic design principles into medical devices and equipment so users intuitively feel comfortable with the product. Design engineers, usability and reliability engineers, software programmers, documentation specialists, product managers, quality engineers, and market/product managers will find this text invaluable in getting usability built into products from the very beginning.