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Medical Device Design

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Medical Device Design

Medical Device Design Book
Author : Peter J. Ogrodnik
Publisher : Academic Press
Release : 2019-10-30
ISBN : 0128149639
Language : En, Es, Fr & De

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Book Description :

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

Handbook of Medical Device Design

Handbook of Medical Device Design Book
Author : Richard C. Fries
Publisher : CRC Press
Release : 2019-08-15
ISBN : 1000693872
Language : En, Es, Fr & De

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Book Description :

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

Medical Device Design Book
Author : Peter J Ogrodnik
Publisher : Academic Press
Release : 2012-12-17
ISBN : 0123919436
Language : En, Es, Fr & De

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Book Description :

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

Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design Book
Author : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
Publisher : CRC Press
Release : 2010-12-13
ISBN : 1420063510
Language : En, Es, Fr & De

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Book Description :

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

Contextual Inquiry for Medical Device Design

Contextual Inquiry for Medical Device Design Book
Author : Mary Beth Privitera
Publisher : Academic Press
Release : 2015-05-29
ISBN : 0128018747
Language : En, Es, Fr & De

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Book Description :

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

Medical Device and Equipment Design

Medical Device and Equipment Design Book
Author : Michael E. Wiklund
Publisher : CRC Press
Release : 1995-02-15
ISBN : 9780935184693
Language : En, Es, Fr & De

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Book Description :

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.

Medical Device Design and Regulation

Medical Device Design and Regulation Book
Author : Carl T. DeMarco
Publisher : Quality Press
Release : 2011-01-01
ISBN : 0873898168
Language : En, Es, Fr & De

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Book Description :

Download Medical Device Design and Regulation book written by Carl T. DeMarco, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Reliable Design of Medical Devices

Reliable Design of Medical Devices Book
Author : Richard C. Fries
Publisher : CRC Press
Release : 1997-01-30
ISBN : 9781420001013
Language : En, Es, Fr & De

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Book Description :

Presenting the basic concepts and major issues associated with medical device design, this text describes current development processes as well as standards and regulatory information, providing a basis for assessing new technologies. It aims to help manufacturers establish and operate a viable reliability assurance programme, and purchasers to formulate effective methods of vendor evaluation.

Design of Biomedical Devices and Systems Third Edition

Design of Biomedical Devices and Systems  Third Edition Book
Author : Paul H. King,Richard C. Fries,Arthur T. Johnson
Publisher : CRC Press
Release : 2014-07-29
ISBN : 1466569131
Language : En, Es, Fr & De

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Book Description :

Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.

Design Controls for the Medical Device Industry Third Edition

Design Controls for the Medical Device Industry  Third Edition Book
Author : Marie B. Teixeira
Publisher : CRC Press
Release : 2019-08-20
ISBN : 1351261460
Language : En, Es, Fr & De

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Book Description :

This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and 13485:2016 standards, but also meets today's Notified Body Auditors' and FDA Investigators' expectations. The book includes a review of the design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe. Practical advice, methods and appendixes are provided to assist with implementation of a compliant design control program and extensive references are provided for further study. This third edition: Examines new coverage of ISO 13485-2016 design control requirements Explores proven techniques and methods for compliance Contributes fresh templates for practical implementation Provides updated chapters with additional details for greater understanding and compliance Offers an easy to understand breakdown of design control requirements Reference to MDSAP design control requirements

Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design Book
Author : Mary Beth Privitera
Publisher : Academic Press
Release : 2019-06-15
ISBN : 0128161647
Language : En, Es, Fr & De

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Book Description :

Applied Human Factors in Medical Device Design describes the contents of a human factors toolbox with in-depth descriptions of both empirical and analytical methodologies. The book begins with an overview of the design control process, integrating human factors as directed by AAMI TIR 59 and experienced practice. It then explains each method, describing why each method is important, its potential impact, when it's ideal to use, and related challenges. Also discussed are other barriers, such as communication breakdowns between users and design teams. This book is an excellent reference for professionals working in human factors, design, engineering, marketing and regulation. Focuses on meeting agency requirements as it pertains to the application of human factors in the medical device development process in both the US and the European Union (EU) Explains technology development and the application of human factors throughout the development process Covers FDA and MHRA regulations Includes case examples with each method

Humanizing Healthcare Human Factors for Medical Device Design

Humanizing Healthcare     Human Factors for Medical Device Design Book
Author : Russell J. Branaghan
Publisher : Springer Nature
Release : 2021-05-07
ISBN : 3030644332
Language : En, Es, Fr & De

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Book Description :

Download Humanizing Healthcare Human Factors for Medical Device Design book written by Russell J. Branaghan, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Frontiers in Medical Device Design

Frontiers in Medical Device Design Book
Author : Anonim
Publisher : Unknown
Release : 2015
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Frontiers in Medical Device Design book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

The Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices Book
Author : J Paulo Davim
Publisher : Elsevier
Release : 2012-10-16
ISBN : 1908818182
Language : En, Es, Fr & De

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Book Description :

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

Reliable Design of Medical Devices Third Edition

Reliable Design of Medical Devices  Third Edition Book
Author : Richard C. Fries
Publisher : CRC Press
Release : 2012-09-06
ISBN : 1439894914
Language : En, Es, Fr & De

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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 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.

Medical Device Design for Six Sigma

Medical Device Design for Six Sigma Book
Author : Basem El-Haik,Khalid S. Mekki
Publisher : John Wiley & Sons
Release : 2011-09-20
ISBN : 1118210417
Language : En, Es, Fr & De

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Book Description :

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.

Therapeutic Medical Devices Application and Design

Therapeutic Medical Devices  Application and Design Book
Author : Albert M. Cook,John G. Webster
Publisher : Prentice Hall
Release : 1982
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Therapeutic Medical Devices Application and Design book written by Albert M. Cook,John G. Webster, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Six Sigma for Medical Device Design

Six Sigma for Medical Device Design Book
Author : Jose Justiniano,Venky Gopalaswamy
Publisher : CRC Press
Release : 2004-11-15
ISBN : 0203485742
Language : En, Es, Fr & De

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Book Description :

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

Design Controls for the Medical Device Industry Second Edition

Design Controls for the Medical Device Industry  Second Edition Book
Author : Marie B. Teixeira
Publisher : CRC Press
Release : 2013-11-12
ISBN : 1466503556
Language : En, Es, Fr & De

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Book Description :

The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses design control elements such as design planning, input, output, review, verification, validation, change, transfer, and history, as well as risk management inclusive of human factors and usability, biocompatibility, the FDA Quality System Inspection Technique (QSIT) for design controls, and medical device regulations and classes in the US, Canada, and Europe.

Medical Devices

Medical Devices Book
Author : Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher : Woodhead Publishing
Release : 2015-08-18
ISBN : 0081002912
Language : En, Es, Fr & De

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Book Description :

Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors’ practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulations Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards Includes a useful case study demonstrating the design and approval process