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Author: Richard C. Fries
Publisher: CRC Press
Published: 2019-08-15
Total Pages: 795
ISBN-13: 1000693872
DOWNLOAD EBOOKFirst 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: Matthew Bret Weinger
Publisher: CRC Press
Published: 2010-12-13
Total Pages: 822
ISBN-13: 1420063510
DOWNLOAD EBOOKDeveloped 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: Richard C. Fries
Publisher: CRC Press
Published: 2019-08-15
Total Pages: 491
ISBN-13: 1000696952
DOWNLOAD EBOOKFirst 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.
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Publisher: Academic Press
Published: 2012-12-17
Total Pages: 369
ISBN-13: 0123919436
DOWNLOAD EBOOKThis 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: Theodore R. Kucklick
Publisher: CRC Press
Published: 2005-11-21
Total Pages: 376
ISBN-13: 1420038354
DOWNLOAD EBOOKThe 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
Author: Michael E. Wiklund
Publisher: CRC Press
Published: 2005-02-11
Total Pages: 285
ISBN-13: 1040063756
DOWNLOAD EBOOKAdvocating 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 o
Author: Vernon Geckler
Publisher: Wasatch Consulting Resources LLC
Published: 2017-02-11
Total Pages: 441
ISBN-13: 0692835415
DOWNLOAD EBOOKThis 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.
Author: Seeram Ramakrishna
Publisher: Woodhead Publishing
Published: 2015-08-18
Total Pages: 253
ISBN-13: 0081002912
DOWNLOAD EBOOKMedical 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
Author: Marie Teixeira
Publisher: CRC Press
Published: 2002-09-20
Total Pages: 258
ISBN-13: 9780203909386
DOWNLOAD EBOOKThis 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
Author: Joseph F. Dyro
Publisher: Academic Press
Published: 2004-08-27
Total Pages: 696
ISBN-13: 012226570X
DOWNLOAD EBOOKAs 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.
