Medical Device And Equipment Design

Author : Michael E. Wiklund
Publisher : CRC Press
Page : 402 pages
File Size : 42,8 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 : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publisher : CRC Press
Page : 844 pages
File Size : 42,5 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

Author : Anonim
Publisher : Academic Press
Page : 369 pages
File Size : 55,9 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 : Richard C. Fries
Publisher : CRC Press
Page : 490 pages
File Size : 45,8 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 : Richard C. Fries
Publisher : CRC Press
Page : 491 pages
File Size : 55,9 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 : Karen Alexander
Publisher : Unknown
Page : 64 pages
File Size : 48,5 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.

Author : Marie B. Teixeira,Richard Bradley
Publisher : CRC Press
Page : 253 pages
File Size : 55,8 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 : Sandra Shefelbine
Publisher : Unknown
Page : 80 pages
File Size : 40,7 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.

Author : Paul H. King,Richard C. Fries
Publisher : CRC Press
Page : 424 pages
File Size : 54,5 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 : Peter J. Ogrodnik
Publisher : Academic Press
Page : 115 pages
File Size : 41,6 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.

Author : Annetine C. Gelijns
Publisher : National Academies
Page : 78 pages
File Size : 50,8 Mb
Release : 1989
Category : Clinical medicine
ISBN : NAP:13516

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Technological Innovation by Annetine C. Gelijns Pdf

Author : James Ward
Publisher : Unknown
Page : 80 pages
File Size : 42,8 Mb
Release : 2002
Category : Medical instruments and apparatus
ISBN : 1902546121

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Good design practice for medical devices and equipment by James Ward Pdf

Case histories show that the effects of releasing a device that is unfit for purpose to market can be catastrophic - for those who use the device and the manufacturer. Medical devices must be proven to be fit for purpose before they are marketed. Part of this proof is given by documenting evidence of design verification activities, which show that device design requirements have been met. This workbook - the third in the series - presents an approach for identifying and selecting verification methods, determining when verification should occur in the design process and ensuring that it is carried out within a commercially viable framework. engineers and project managers in the healthcare manufacturing industry. Readers will benefit from having had some previous experience of medical device design.

Author : Richard C. Fries
Publisher : CRC Press
Page : 505 pages
File Size : 46,8 Mb
Release : 2012-09-06
Category : Medical
ISBN : 9781439894910

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Reliable Design of Medical Devices, Third Edition by Richard C. Fries Pdf

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 Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Page : 152 pages
File Size : 47,8 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 : Mary Beth Privitera
Publisher : Academic Press
Page : 307 pages
File Size : 43,8 Mb
Release : 2015-05-29
Category : Technology & Engineering
ISBN : 9780128018743

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Contextual Inquiry for Medical Device Design by Mary Beth Privitera Pdf

Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technology Helps users understand the everyday use of medical devices and the way their usage supports the development of better products Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process