Practical Design And Applications Of Medical Devices

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Practical Design and Applications of Medical Devices

Author : Dilber Uzun Ozsahin,Ilker Ozsahin
Publisher : Elsevier
Page : 349 pages
File Size : 45,9 Mb
Release : 2023-11-25
Category : Computers
ISBN : 9780443141324

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Practical Design and Applications of Medical Devices by Dilber Uzun Ozsahin,Ilker Ozsahin Pdf

Practical Design and Applications of Medical Devices focuses on advanced medical device development featuring various biomedical instruments and their applications. The book focuses on devices which receive and transmit bioelectric signals, such as electrocardiograph, electrodes, blood flow, blood pressure, physiological effects and, in some cases, current flowing through the human body. A thorough guide for researchers and engineers in the field of biomedical and instrumentation engineering, this book presents a streamlined medical strategy for designing these medical devices, sensors, and tools. It also promotes operational efficiency in the healthcare industry, with the goals of improving patient safety, lowering overall healthcare costs, broadening access to healthcare services, and improving accessibility. Covers the fundamental principles of medical and biological instrumentation, as well as the typical features of its design and construction Provides various methods of designing modern medical devices Focuses on specific devices with detailed functions, applications, and how they measure and transmit data

Practical Design Control Implementation for Medical Devices

Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Page : 232 pages
File Size : 47,9 Mb
Release : 2019-08-30
Category : Electronic
ISBN : 036739538X

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Practical Design Control Implementation for Medical Devices by Jose Justiniano,Venky Gopalaswamy Pdf

Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Class 1 Devices

Author : Peter J Ogrodnik
Publisher : Academic Press
Page : 114 pages
File Size : 40,9 Mb
Release : 2014-11-24
Category : Technology & Engineering
ISBN : 9780128007969

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Class 1 Devices by Peter J Ogrodnik Pdf

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.

Medical Device and Equipment Design

Author : Michael E. Wiklund
Publisher : CRC Press
Page : 402 pages
File Size : 52,7 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.

Reliable Design of Medical Devices

Author : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 42,9 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.

Design and Development of Medical Electronic Instrumentation

Author : David Prutchi,Michael Norris
Publisher : John Wiley & Sons
Page : 479 pages
File Size : 40,9 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.

Handbook of Human Factors in Medical Device Design

Author : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publisher : CRC Press
Page : 844 pages
File Size : 53,8 Mb
Release : 2010-12-13
Category : Technology & Engineering
ISBN : 9781420063516

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Handbook of Human Factors in Medical Device Design by Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau Pdf

Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance

Good Design Practice for Medical Devices and Equipment

Author : Karen Alexander
Publisher : Unknown
Page : 64 pages
File Size : 49,7 Mb
Release : 2001
Category : Medical instruments and apparatus
ISBN : 1902546083

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Good Design Practice for Medical Devices and Equipment by Karen Alexander Pdf

The objective of this workbook is to help people design medical devices and equipment that are easier and more economical to validate. The book has been developed to satisfy an industry need for guidance to support concurrent design development and validation.

Handbook of Medical Device Design

Author : Richard C. Fries
Publisher : CRC Press
Page : 795 pages
File Size : 46,5 Mb
Release : 2019-08-15
Category : Technology & Engineering
ISBN : 9781000693874

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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.

Medical Device Design

Author : Peter J. Ogrodnik
Publisher : Academic Press
Page : 538 pages
File Size : 48,7 Mb
Release : 2019-10-30
Category : Technology & Engineering
ISBN : 9780128149638

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Medical Device Design by Peter J. Ogrodnik Pdf

Medical Device Design: Innovation from Concept to Market, Second Edition 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; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns

Medical Device Design

Author : Anonim
Publisher : Academic Press
Page : 369 pages
File Size : 45,8 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

The Design and Manufacture of Medical Devices

Author : J Paulo Davim
Publisher : Elsevier
Page : 386 pages
File Size : 40,6 Mb
Release : 2012-10-16
Category : Medical
ISBN : 9781908818188

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The Design and Manufacture of Medical Devices by J Paulo Davim Pdf

Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device Offers a practical approach to recent developments in the design and manufacture of medical devices Presents a topic that is the focus of research in many important universities and centres of research worldwide

Good Design Practice for Medical Devices and Equipment

Author : Sandra Shefelbine
Publisher : Unknown
Page : 80 pages
File Size : 52,6 Mb
Release : 2002
Category : Medical instruments and apparatus
ISBN : 1902546105

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Good Design Practice for Medical Devices and Equipment by Sandra Shefelbine Pdf

Due to the direct health and safety effects they have on users, medical devices are subject to many regulations and must undergo extensive validation procedures before they are allowed on the market. Requirements formulation is one of the most important aspects of the design process because it lays the foundation for the rest of the design.

Plastics in Medical Devices

Author : Vinny R. Sastri
Publisher : Elsevier
Page : 289 pages
File Size : 47,8 Mb
Release : 2010-03-05
Category : Technology & Engineering
ISBN : 9780815520283

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Plastics in Medical Devices by Vinny R. Sastri Pdf

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Biomedical Devices

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 : 44,7 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