Handbook Of Medical Device Design
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Handbook Of Medical Device Design
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Author : Richard C. Fries
language : en
Publisher: CRC Press
Release Date : 2000-09-14
Handbook Of Medical Device Design written by Richard C. Fries and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-09-14 with Medical categories.
The Handbook of Medical Device Design provides a review of regulatory and standards issues in medical device design, including FDA regulations, types of 510 (k), the ISO 9000 series, and medical device directives. It identifies how to determine and document customer needs and device requirements. It also establishes reliability and quality metrics for the duration of the product development cycle. Topics include
Handbook Of Human Factors In Medical Device Design
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Author : Matthew Bret Weinger
language : en
Publisher: CRC Press
Release Date : 2010-12-13
Handbook Of Human Factors In Medical Device Design written by Matthew Bret Weinger and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-13 with Technology & Engineering categories.
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 Design
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Author :
language : en
Publisher: Academic Press
Release Date : 2012-12-17
Medical Device Design written by and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-17 with Technology & Engineering categories.
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 Medical Device Design
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Author : Richard C. Fries
language : en
Publisher: CRC Press
Release Date : 2019-08-15
Handbook Of Medical Device Design written by Richard C. Fries and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-15 with Technology & Engineering categories.
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 Medical Device R D Handbook
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Author : Theodore R. Kucklick
language : en
Publisher: CRC Press
Release Date : 2005-11-21
The Medical Device R D Handbook written by Theodore R. Kucklick and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-21 with Medical categories.
The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha
Medical Device Design And Regulation
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Author : Carl T. DeMarco
language : en
Publisher: Quality Press
Release Date : 2011-01-01
Medical Device Design And Regulation written by Carl T. DeMarco and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-01-01 with Business & Economics categories.
Handbook Of Polymer Applications In Medicine And Medical Devices
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Author : Kayvon Modjarrad
language : en
Publisher: Elsevier
Release Date : 2013-12-05
Handbook Of Polymer Applications In Medicine And Medical Devices written by Kayvon Modjarrad and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-05 with Medical categories.
While the prevalence of plastics and elastomers in medical devices is now quite well known, there is less information available covering the use of medical devices and the applications of polymers beyond medical devices, such as in hydrogels, biopolymers and silicones beyond enhancement applications, and few books in which these are combined into a single reference. This book is a comprehensive reference source, bringing together a number of key medical polymer topics in one place for a broad audience of engineers and scientists, especially those currently developing new medical devices or seeking more information about current and future applications. In addition to a broad range of applications, the book also covers clinical outcomes and complications arising from the use of the polymers in the body, giving engineers a vital insight into the real world implications of the devices they're creating. Regulatory issues are also covered in detail. The book also presents the latest developments on the use of polymers in medicine and development of nano-scale devices. - Gathers discussions of a large number of applications of polymers in medicine in one place - Provides an insight into both the legal and clinical implications of device design - Relevant to industry, academic and medical professionals - Presents the latest developments in the field, including medical devices on a nano-scale
Clinical Engineering Handbook
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Author : Joseph F. Dyro
language : en
Publisher: Academic Press
Release Date : 2004-08-27
Clinical Engineering Handbook written by Joseph F. Dyro and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-08-27 with Medical categories.
As the biomedical engineering field expands throughout the world, clinical engineers play an ever more important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical engineers were key players in calming the hysteria over electrical safety in the 1970s and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world.
Design Controls For The Medical Device Industry
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Author : Marie Teixeira
language : en
Publisher: CRC Press
Release Date : 2002-09-20
Design Controls For The Medical Device Industry written by Marie Teixeira and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-09-20 with Medical categories.
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
Design Controls Risk Management Process Validation For Medical Device Professionals
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Author : Vernon M. Geckler
language : en
Publisher: Wasatch Consulting Resources LLC
Release Date : 2017-02-11
Design Controls Risk Management Process Validation For Medical Device Professionals written by Vernon M. Geckler and has been published by Wasatch Consulting Resources LLC this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-11 with Law categories.
This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.