Medical Instrument Design And Development

Author : Claudio Becchetti,Alessandro Neri
Publisher : John Wiley & Sons
Page : 612 pages
File Size : 53,5 Mb
Release : 2013-07-29
Category : Science
ISBN : 9781119952404

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Medical Instrument Design and Development by Claudio Becchetti,Alessandro Neri Pdf

This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing 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 (using ECG as an example) Examines the design and applications of main medical instruments Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc. Includes an accompanying website with the design of the certified ECG product (www.gammacardiosoft.it/book) Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.

Author : Claudio Becchetti,Alessandro Neri
Publisher : John Wiley & Sons
Page : 600 pages
File Size : 51,8 Mb
Release : 2013-05-20
Category : Science
ISBN : 9781118652466

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Medical Instrument Design and Development by Claudio Becchetti,Alessandro Neri Pdf

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.

Author : David Prutchi,Michael Norris
Publisher : John Wiley & Sons
Page : 479 pages
File Size : 48,8 Mb
Release : 2005-01-28
Category : Technology & Engineering
ISBN : 9780471681830

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Design and Development of Medical Electronic Instrumentation by David Prutchi,Michael Norris Pdf

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.

Author : Anonim
Publisher : Academic Press
Page : 369 pages
File Size : 42,9 Mb
Release : 2012-12-17
Category : Technology & Engineering
ISBN : 9780123919434

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Medical Device Design by Anonim Pdf

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

Author : Jack M. Winters,Molly Follette Story
Publisher : CRC Press
Page : 474 pages
File Size : 53,7 Mb
Release : 2006-10-31
Category : Medical
ISBN : 9781000654172

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Medical Instrumentation by Jack M. Winters,Molly Follette Story Pdf

Two of the most important yet often overlooked aspects of a medical device are its usability and accessibility. This is important not only for health care providers, but also for older patients and users with disabilities or activity limitations. Medical Instrumentation: Accessibility and Usability Considerations focuses on how lack of usabi

Author : Michael E. Wiklund
Publisher : CRC Press
Page : 402 pages
File Size : 51,8 Mb
Release : 1995-02-15
Category : Technology & Engineering
ISBN : 0935184694

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Medical Device and Equipment Design by Michael E. Wiklund Pdf

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.

Author : Richard C. Fries
Publisher : CRC Press
Page : 491 pages
File Size : 41,7 Mb
Release : 2019-08-15
Category : Medical
ISBN : 9781000696950

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Handbook of Medical Device Design by Richard C. Fries Pdf

First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.

Author : Marie B. Teixeira,Richard Bradley
Publisher : CRC Press
Page : 253 pages
File Size : 55,5 Mb
Release : 2002-09-20
Category : Medical
ISBN : 9780824743550

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Design Controls for the Medical Device Industry by Marie B. Teixeira,Richard Bradley Pdf

This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.

Author : Annetine C. Gelijns
Publisher : National Academies
Page : 78 pages
File Size : 45,6 Mb
Release : 1989
Category : Clinical medicine
ISBN : NAP:13516

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Technological Innovation by Annetine C. Gelijns Pdf

Author : Paul H. King,Richard C. Fries
Publisher : CRC Press
Page : 424 pages
File Size : 48,6 Mb
Release : 2008-08-22
Category : Medical
ISBN : 9781439878071

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Design of Biomedical Devices and Systems Second edition by Paul H. King,Richard C. Fries Pdf

The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This

Author : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 40,6 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420027945

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Reliable Design of Medical Devices by Richard C. Fries Pdf

As medical devices increase in complexity, concerns about efficacy, safety, quality, and longevity increase in stride. Introduced nearly a decade ago, Reliable Design of Medical Devices illuminated the path to increased reliability in the hands-on design of advanced medical devices. With fully updated coverage in its Second Edition, this practical guide continues to be the benchmark for incorporating reliability engineering as a fundamental design philosophy. The book begins by rigorously defining reliability, differentiating it from quality, and exploring various aspects of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Author : Basem El-Haik,Khalid S. Mekki
Publisher : John Wiley & Sons
Page : 528 pages
File Size : 50,8 Mb
Release : 2011-09-20
Category : Medical
ISBN : 9781118210413

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Medical Device Design for Six Sigma by Basem El-Haik,Khalid S. Mekki Pdf

The first comprehensive guide to the integration of Design forSix Sigma principles in the medical devices development cycle Medical Device Design for Six Sigma: A Road Map for Safetyand Effectiveness presents the complete body of knowledge forDesign for Six Sigma (DFSS), as outlined by American Society forQuality, and details how to integrate appropriate designmethodologies up front in the design process. DFSS helps companiesshorten lead times, cut development and manufacturing costs, lowertotal life-cycle cost, and improve the quality of the medicaldevices. Comprehensive and complete with real-world examples, thisguide: Integrates concept and design methods such as Pugh ControlledConvergence approach, QFD methodology, parameter optimizationtechniques like Design of Experiment (DOE), Taguchi Robust Designmethod, Failure Mode and Effects Analysis (FMEA), Design for X,Multi-Level Hierarchical Design methodology, and Response Surfacemethodology Covers contemporary and emerging design methods, includingAxiomatic Design Principles, Theory of Inventive Problem Solving(TRIZ), and Tolerance Design Provides a detailed, step-by-step implementation process foreach DFSS tool included Covers the structural, organizational, and technical deploymentof DFSS within the medical device industry Includes a DFSS case study describing the development of a newdevice Presents a global prospective of medical device regulations Providing both a road map and a toolbox, this is a hands-onreference for medical device product development practitioners,product/service development engineers and architects, DFSS and SixSigma trainees and trainers, middle management, engineering teamleaders, quality engineers and quality consultants, and graduatestudents in biomedical engineering.

Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Page : 152 pages
File Size : 46,6 Mb
Release : 2004-11-15
Category : Science
ISBN : 9780203485743

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Six Sigma for Medical Device Design by Jose Justiniano,Venky Gopalaswamy Pdf

For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do

Author : Tugrul Özel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
Publisher : John Wiley & Sons
Page : 212 pages
File Size : 54,8 Mb
Release : 2016-10-24
Category : Science
ISBN : 9781118478929

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Biomedical Devices by Tugrul Özel,Paolo Jorge Bártolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva Pdf

Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

Author : Theodore R. Kucklick
Publisher : CRC Press
Page : 376 pages
File Size : 47,5 Mb
Release : 2005-11-21
Category : Medical
ISBN : 9781420038354

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The Medical Device R&D Handbook by Theodore R. Kucklick Pdf

The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha