Medical Device Design

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

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  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Pages : 376 pages
  • ISBN : 0123919436
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKMedical Device Design

Medical Device Design

Medical Device Design
  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release : 17 December 2012
GET THIS BOOKMedical Device Design

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

Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design
  • Author : Matthew Bret Weinger,Michael E. Wiklund,Daryle Jean Gardner-Bonneau
  • Publisher : CRC Press
  • Release : 13 December 2010
GET THIS BOOKHandbook of Human Factors in Medical Device Design

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

Medical Device and Equipment Design

Medical Device and Equipment Design
  • Author : Michael E. Wiklund
  • Publisher : CRC Press
  • Release : 15 February 1995
GET THIS BOOKMedical Device and Equipment Design

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

Applied Human Factors in Medical Device Design

Applied Human Factors in Medical Device Design
  • Author : Mary Beth Privitera
  • Publisher : Academic Press
  • Release : 15 June 2019
GET THIS BOOKApplied Human Factors in Medical Device Design

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

Contextual Inquiry for Medical Device Design

Contextual Inquiry for Medical Device Design
  • Author : Mary Beth Privitera
  • Publisher : Academic Press
  • Release : 29 May 2015
GET THIS BOOKContextual Inquiry for Medical Device Design

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

Six Sigma for Medical Device Design

Six Sigma for Medical Device Design
  • Author : Jose Justiniano,Venky Gopalaswamy
  • Publisher : CRC Press
  • Release : 15 November 2004
GET THIS BOOKSix Sigma for Medical Device Design

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

Medical Device Design

Medical Device Design
  • Author : Peter J. Ogrodnik
  • Publisher : Academic Press
  • Release : 30 October 2019
GET THIS BOOKMedical Device Design

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

Design Controls for the Medical Device Industry

Design Controls for the Medical Device Industry
  • Author : Marie Teixeira,Richard Bradley
  • Publisher : CRC Press
  • Release : 20 September 2002
GET THIS BOOKDesign Controls for the Medical Device Industry

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 utilize

Reliable Design of Medical Devices

Reliable Design of Medical Devices
  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release : 21 November 2005
GET THIS BOOKReliable Design of Medical Devices

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

Medical Device Design for Six Sigma

Medical Device Design for Six Sigma
  • Author : Basem El-Haik,Khalid S. Mekki
  • Publisher : John Wiley & Sons
  • Release : 20 September 2011
GET THIS BOOKMedical Device Design for Six Sigma

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.

Handbook of Medical Device Design

Handbook of Medical Device Design
  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release : 15 August 2019
GET THIS BOOKHandbook of Medical Device Design

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.

The Design and Manufacture of Medical Devices

The Design and Manufacture of Medical Devices
  • Author : J Paulo Davim
  • Publisher : Elsevier
  • Release : 16 October 2012
GET THIS BOOKThe Design and Manufacture of Medical Devices

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

Medical Instrument Design and Development

Medical Instrument Design and Development
  • Author : Claudio Becchetti,Alessandro Neri
  • Publisher : John Wiley & Sons
  • Release : 20 May 2013
GET THIS BOOKMedical Instrument Design and Development

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

Designing Usability into Medical Products

Designing Usability into Medical Products
  • Author : Michael E. Wiklund,Stephen B. Wilcox
  • Publisher : CRC Press
  • Release : 11 February 2005
GET THIS BOOKDesigning Usability into Medical Products

Advocating a user-centered approach to medical technology design, Designing Usability into Medical Products covers the essential processes and specific techniques necessary to produce safe, effective, usable, and appealing medical systems and products. Written by experts on user-centered research, design, and evaluation, the book provides a range of alternative approaches to the subject. Wiklund and Wilcox explore how to make medical devices safe and effective by involving users in the design process. They discuss specific design and evaluation methods and tools,