Design of Biomedical Devices and Systems, Third Edition

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Publisher : CRC Press
ISBN 13 : 1466569131
Total Pages : 520 pages
Book Rating : 4.4/5 (665 download)

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Book Synopsis Design of Biomedical Devices and Systems, Third Edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems, Third Edition written by Paul H. King and published by CRC Press. This book was released on 2014-07-29 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 of Biomedical Devices and Systems Second edition

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Publisher : CRC Press
ISBN 13 : 1439878072
Total Pages : 424 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Design of Biomedical Devices and Systems Second edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems Second edition written by Paul H. King and published by CRC Press. This book was released on 2008-08-22 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This

Design of Biomedical Devices and Systems, 4th edition

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Publisher : CRC Press
ISBN 13 : 0429786069
Total Pages : 508 pages
Book Rating : 4.4/5 (297 download)

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Book Synopsis Design of Biomedical Devices and Systems, 4th edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems, 4th edition written by Paul H. King and published by CRC Press. This book was released on 2018-10-03 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes

Design of Biomedical Devices and Systems, Second Edition

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Publisher : CRC Press
ISBN 13 : 9781420061796
Total Pages : 0 pages
Book Rating : 4.0/5 (617 download)

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Book Synopsis Design of Biomedical Devices and Systems, Second Edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems, Second Edition written by Paul H. King and published by CRC Press. This book was released on 2008-08-22 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This edition of a bestselling textbook utilizes a strong design perspective to provide designers with a thorough overview of the field, including topics related to databases, process analysis, and device improvement. Covers All Necessary Design Aspects for Advanced Biomedical Projects Designed primarily for senior bioengineering students in the formative stages of planning their design project, Design of Biomedical Devices and Systems is also beneficial to graduate students in the field and practitioners working with medical devices. This standard-setting resource includes: A variety of open-ended design problems and examples An overview of device definitions and reliability A discussion of testing and hardware verification and validation principles Detailed photographs and illustrations within each chapter Systematic approaches to device development and maintenance are mandated to ensure safe and effective devices for the patient, an economical and competitive success for the manufacturer, and a reliable, cost-effective investment for the user. This authoritative textbook answers the call. A solutions manual is available for instructors wishing to convert this reference to classroom use.

Design of Biomedical Devices and Systems, 4th edition

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Publisher : CRC Press
ISBN 13 : 0429786050
Total Pages : 725 pages
Book Rating : 4.4/5 (297 download)

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Book Synopsis Design of Biomedical Devices and Systems, 4th edition by : Paul H. King

Download or read book Design of Biomedical Devices and Systems, 4th edition written by Paul H. King and published by CRC Press. This book was released on 2018-10-03 with total page 725 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes

Design Controls for the Medical Device Industry

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Publisher : CRC Press
ISBN 13 : 9780203909386
Total Pages : 258 pages
Book Rating : 4.9/5 (93 download)

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Book Synopsis Design Controls for the Medical Device Industry by : Marie Teixeira

Download or read book Design Controls for the Medical Device Industry written by Marie Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 of Biomedical Devices and Systems

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Publisher : CRC Press
ISBN 13 : 9781138723061
Total Pages : 542 pages
Book Rating : 4.7/5 (23 download)

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Book Synopsis Design of Biomedical Devices and Systems by : Paul H. King

Download or read book Design of Biomedical Devices and Systems written by Paul H. King and published by CRC Press. This book was released on 2018-10-15 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A CRC title, part of the Taylor & Francis imprint, a member of the Taylor & Francis Group, the academic division of T&F Informa plc."

Reliable Design of Medical Devices

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Author :
Publisher : CRC Press
ISBN 13 : 1420027948
Total Pages : 490 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 of failure in detail. It examines domestic and international regulations and standards in similar depth, including updated information on the regulatory and standards organizations as well as a new chapter on quality system regulation. The author builds on this background to explain product specification, liability and intellectual property, safety and risk management, design, testing, human factors, and manufacturing. New topics include design of experiments, CAD/CAM, industrial design, material selection and biocompatibility, system engineering, rapid prototyping, quick-response manufacturing, and maintainability as well as a new chapter on Six Sigma for design. Supplying valuable insight based on years of successful experience, Reliable Design of Medical Devices, Second Edition leads the way to implementing an effective reliability assurance program and navigating the regulatory minefield with confidence.

Plastics in Medical Devices

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Author :
Publisher : Elsevier
ISBN 13 : 081552028X
Total Pages : 289 pages
Book Rating : 4.8/5 (155 download)

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Book Synopsis Plastics in Medical Devices by : Vinny R. Sastri

Download or read book Plastics in Medical Devices written by Vinny R. Sastri and published by Elsevier. This book was released on 2010-03-05 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Design Controls for the Medical Device Industry, Third Edition

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Publisher : CRC Press
ISBN 13 : 1351261460
Total Pages : 185 pages
Book Rating : 4.3/5 (512 download)

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Book Synopsis Design Controls for the Medical Device Industry, Third Edition by : Marie B. Teixeira

Download or read book Design Controls for the Medical Device Industry, Third Edition written by Marie B. Teixeira and published by CRC Press. This book was released on 2019-08-02 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Reliable Design of Medical Devices

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Author :
Publisher : CRC Press
ISBN 13 : 1439894949
Total Pages : 501 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Reliable Design of Medical Devices by : Richard C. Fries

Download or read book Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2016-04-19 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 D

Biomedical Engineering Design

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Author :
Publisher : Academic Press
ISBN 13 : 0128166258
Total Pages : 529 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biomedical Engineering Design by : Joseph Tranquillo

Download or read book Biomedical Engineering Design written by Joseph Tranquillo and published by Academic Press. This book was released on 2022-02-19 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Engineering Design presents the design processes and practices used in academic and industry medical device design projects. The first two chapters are an overview of the design process, project management and working on technical teams. Further chapters follow the general order of a design sequence in biomedical engineering, from problem identification to validation and verification testing. The first seven chapters, or parts of them, can be used for first-year and sophomore design classes. The next six chapters are primarily for upper-level students and include in-depth discussions of detailed design, testing, standards, regulatory requirements and ethics. The last two chapters summarize the various activities that industry engineers might be involved in to commercialize a medical device. Covers subject matter rarely addressed in other BME design texts, such as packaging design, testing in living systems and sterilization methods Provides instructive examples of how technical, marketing, regulatory, legal, and ethical requirements inform the design process Includes numerous examples from both industry and academic design projects that highlight different ways to navigate the stages of design as well as document and communicate design decisions Provides comprehensive coverage of the design process, including methods for identifying unmet needs, applying Design for ‘X’, and incorporating standards and design controls Discusses topics that prepare students for careers in medical device design or other related medical fields

Biomedical Device Technology

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Publisher :
ISBN 13 : 9780398091255
Total Pages : pages
Book Rating : 4.0/5 (912 download)

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Book Synopsis Biomedical Device Technology by : Anthony Y. K. Chan

Download or read book Biomedical Device Technology written by Anthony Y. K. Chan and published by . This book was released on 2016-06-03 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: With this resource, instructors can create custom slide shows and presentations using the 388 illustrations and 53 tables from Biomedical Device Technology: Principles and Design (2nd Ed.). This CD contains all the images, figures and tables included in the textbook in JPG format.

Medical Device Design

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Publisher : Academic Press
ISBN 13 : 0123919436
Total Pages : 376 pages
Book Rating : 4.1/5 (239 download)

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Book Synopsis Medical Device Design by : Peter J Ogrodnik

Download or read book Medical Device Design written by Peter J Ogrodnik and published by Academic Press. This book was released on 2012-12-17 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Biomedical Device Technology (3rd Edition)

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Publisher : Charles C Thomas Publisher
ISBN 13 : 0398093938
Total Pages : 913 pages
Book Rating : 4.3/5 (98 download)

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Book Synopsis Biomedical Device Technology (3rd Edition) by : Anthony Y. K. Chan

Download or read book Biomedical Device Technology (3rd Edition) written by Anthony Y. K. Chan and published by Charles C Thomas Publisher. This book was released on 2023-02-02 with total page 913 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive approach to studying the principles and design of biomedical devices and their applications in medicine. It is written for engineers and technologists who are interested in understanding the principles, design, and use of medical device technology. The book is also intended to be a textbook or reference for biomedical device technology courses in universities and colleges. It focuses on the applications, functions and principles of medical devices (which are the invariant components) and uses specific designs and constructions to illustrate the concepts where appropriate. Indication of use as well as common problems and hazards for each device type are included. This book selectively covers diagnostic and therapeutic devices that are either commonly used or whose principles and design represent typical applications of the technology. For those who would like to know more, a collection of published papers and book references has been added to the end of each chapter. In this third edition, many chapters have gone through revisions, some with significant updates and additions, to keep up with new applications and advancements in medical technology. A new appendix on infection prevention and control practices relating to medical devices is included. Based on requests, review questions are added for each chapter to help readers to assess their comprehension of the content material.

Medical Device Technologies

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Publisher : Academic Press
ISBN 13 : 012374976X
Total Pages : 529 pages
Book Rating : 4.1/5 (237 download)

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Book Synopsis Medical Device Technologies by : Gail D. Baura

Download or read book Medical Device Technologies written by Gail D. Baura and published by Academic Press. This book was released on 2011-10-07 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Device Technologies introduces undergraduate engineering students to commonly manufactured medical devices. It is the first textbook that discusses both electrical and mechanical medical devices. The first 20 chapters are medical device technology chapters; the remaining eight chapters focus on medical device laboratory experiments. Each medical device chapter begins with an exposition of appropriate physiology, mathematical modeling or biocompatibility issues, and clinical need. A device system description and system diagram provide details on technology function and administration of diagnosis and/or therapy. The systems approach lets students quickly identify the relationships between devices. Device key features are based on five applicable consensus standard requirements from organizations such as ISO and the Association for the Advancement of Medical Instrumentation (AAMI). The medical devices discussed are Nobel Prize or Lasker Clinical Prize winners, vital signs devices, and devices in high industry growth areas Three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation are included in appropriate device chapters Exercises at the end of each chapter include traditional homework problems, analysis exercises, and four questions from assigned primary literature Eight laboratory experiments are detailed that provide hands-on reinforcement of device concepts

Medical Regulatory Affairs

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Publisher : CRC Press
ISBN 13 : 1000440516
Total Pages : 806 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis Medical Regulatory Affairs by : Jack Wong

Download or read book Medical Regulatory Affairs written by Jack Wong and published by CRC Press. This book was released on 2022-01-27 with total page 806 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.