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Design of Biomedical Devices and Systems

Design of Biomedical Devices and Systems
Author: Dragan Primorac
Publisher: CRC Press
Total Pages: 494
Release: 2014-07-29
Genre: Medical
ISBN: 146656914X

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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, 4th edition

Design of Biomedical Devices and Systems, 4th edition
Author: Paul H. King
Publisher: CRC Press
Total Pages: 508
Release: 2018-10-03
Genre: Medical
ISBN: 0429786069

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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, 4th edition

Design of Biomedical Devices and Systems, 4th edition
Author: Paul H. King
Publisher: CRC Press
Total Pages: 725
Release: 2018-10-03
Genre: Medical
ISBN: 0429786050

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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

Design of Biomedical Devices and Systems Second edition
Author: Paul H. King
Publisher: CRC Press
Total Pages: 424
Release: 2008-08-22
Genre: Medical
ISBN: 1439878072

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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


Biomedical Devices

Biomedical Devices
Author: Tugrul Özel
Publisher: John Wiley & Sons
Total Pages: 225
Release: 2016-09-12
Genre: Science
ISBN: 1119267048

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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


Design Controls for the Medical Device Industry, Third Edition

Design Controls for the Medical Device Industry, Third Edition
Author: Marie B. Teixeira
Publisher: CRC Press
Total Pages: 248
Release: 2019-08-02
Genre: Medical
ISBN: 1351261479

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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


Developing Biomedical Devices

Developing Biomedical Devices
Author: Giuseppe Andreoni
Publisher: Springer Science & Business Media
Total Pages: 90
Release: 2013-09-24
Genre: Technology & Engineering
ISBN: 331901207X

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During the past two decades incredible progress has been achieved in the instruments and devices used in the biomedical field. This progress stems from continuous scientific research that has taken advantage of many findings and advances in technology made available by universities and industry. Innovation is the key word and in this context legal protection and intellectual property rights (IPR) are of crucial importance. This book provides students and practitioners with the fundamentals for designing biomedical devices and explains basic design principles. Furthermore, as an aid to the development of devices and products for healthcare, it presents a brief description of the human body, covering anatomy and physiology, that will assist the reader in understanding the origin of biosignals, their significance and the technology to be used in their measurement. Issues concerning IPR and protections are also fully discussed, with examples and opportunities for IPR exploitation.


Medical Device Design

Medical Device Design
Author:
Publisher: Academic Press
Total Pages: 369
Release: 2012-12-17
Genre: Technology & Engineering
ISBN: 0123919436

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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


Design of Medical Electronic Devices

Design of Medical Electronic Devices
Author: Reinaldo Perez
Publisher: Elsevier
Total Pages: 294
Release: 2002-03-21
Genre: Technology & Engineering
ISBN: 008049109X

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The design of medical electronics is unique because of the background needed by the engineers and scientists involved. Often the designer is a medical or life science professional without any training in electronics or design. Likewise, few engineers are specifically trained in biomedical engineering and have little or no exposure to the specific medical requirements of these devices. Design of Medical Electronic Devices presents all essential topics necessary for basic and advanced design. All aspects of the electronics of medical devices are also covered. This is an essential book for graduate students as well as professionals involved in the design of medical equipment. Covers every stage of the process, from design to manufacturing to implementation Topics covered include analogue/digital conversions, data acquisition, signal processing, optics, and reliability and failure


Medical Device Technologies

Medical Device Technologies
Author: Gail D. Baura
Publisher: Academic Press
Total Pages: 529
Release: 2011-10-07
Genre: Science
ISBN: 012374976X

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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