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The Design And Manufacture Of Medical Devices

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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

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

Biomedical Devices

Biomedical Devices Book
Author : Tŭgrul ?zel,Paolo Jorge B?rtolo,Elisabetta Ceretti,Joaquim De Ciurana Gay,Ciro Angel Rodriguez,Jorge Vicente Lopes Da Silva
Publisher : John Wiley & Sons
Release : 2016-10-24
ISBN : 1118478924
Language : En, Es, Fr & De

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Book Description :

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

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.

Design Control and Manufacture of Medical Devices for Engineers

Design Control and Manufacture of Medical Devices for Engineers Book
Author : Priscilla Browne
Publisher : Independently Published
Release : 2019-03-17
ISBN : 9781090217783
Language : En, Es, Fr & De

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Book Description :

The aim of the short book is to provide an understanding of the importance of design controls in device quality and safety for the patient and end user. Design controls interact with main elements of a companies quality management system and they have a continual role in post market surveillance and maintaining the product design throughout its lifecycle. Design Control and their statutory regulations ensure that good quality management (QM) practices are used for the design of medical devices and products remain consistent with quality management systemsDesign controls increase the probability that the design transferred to production will result in a medical device that performs and functions as intended and meets the user's needs. Providing a safe and effective medical device is critical for the success of any firm or manufacturing company. This book covers the nine main areas of design control listed below. It is an ideal desktop companion or resource for those new to design controls or those impacted by them. Short Concise (Paperback book- 99 pages)

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 Instrumentation

Medical Instrumentation Book
Author : Anonim
Publisher : Unknown
Release : 1976
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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

Official Journal of the European Communities

Official Journal of the European Communities Book
Author : Anonim
Publisher : Unknown
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Official Journal of the European Communities book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Business and the Internet

Business and the Internet Book
Author : Anonim
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Business and the Internet book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Guide to Good Manufacturing Practice for Medical Equipment

Guide to Good Manufacturing Practice for Medical Equipment Book
Author : Dhss
Publisher : Unknown
Release : 1983
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

This guide specifies requirements for a system for the assurance of quality in the design, manufacture and installation of medical equip- ment, and for the purpose of this guide medical equipment is defined as those medical devices relying on a power source of their function. This guide specifies minimum quality system requirements for applica- tion to medical equipment, the technical requirements of which are specified principally in terms of the performance required, or for which the design has not been established.

Chemical Week

Chemical Week Book
Author : Anonim
Publisher : Unknown
Release : 1997
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Chemical Week book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Plastics in Medical Devices

Plastics in Medical Devices Book
Author : Vinny R. Sastri
Publisher : William Andrew
Release : 2013-11-27
ISBN : 0323265634
Language : En, Es, Fr & De

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Book Description :

Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else. Comprehensive coverage of uses of polymers for medical devices. Unique coverage of medical device regulatory aspects, supplier control and process validation. Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices.

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.

Thomas Register of American Manufacturers

Thomas Register of American Manufacturers Book
Author : Anonim
Publisher : Unknown
Release : 2002
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

This basic source for identification of U.S. manufacturers is arranged by product in a large multi-volume set. Includes: Products & services, Company profiles and Catalog file.

Photonics Spectra

Photonics Spectra Book
Author : Anonim
Publisher : Unknown
Release : 1993
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Photonics Spectra book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Design of Facilities for Manufacture of Medical Devices Diagnostic Products

Design of Facilities for Manufacture of Medical Devices   Diagnostic Products Book
Author : Leroy Leslie Hamilton,G. Briggs Phillips,Lawrence J. Worden
Publisher : Unknown
Release : 1978
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Design of Facilities for Manufacture of Medical Devices Diagnostic Products book written by Leroy Leslie Hamilton,G. Briggs Phillips,Lawrence J. Worden, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Design News

Design News Book
Author : Anonim
Publisher : Unknown
Release : 1998
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

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

Reports of Selected Cases Decided in Courts of the State of New York Other Than the Court of Appeals and the Appellate Division of the Supreme Court

Reports of Selected Cases Decided in Courts of the State of New York Other Than the Court of Appeals and the Appellate Division of the Supreme Court Book
Author : New York (State). Courts
Publisher : Unknown
Release : 1995
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Reports of Selected Cases Decided in Courts of the State of New York Other Than the Court of Appeals and the Appellate Division of the Supreme Court book written by New York (State). Courts, 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.