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Design Engineering Of Biomaterials For Medical Devices
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Book Synopsis Design Engineering of Biomaterials for Medical Devices by : David Hill
Download or read book Design Engineering of Biomaterials for Medical Devices written by David Hill and published by Wiley. This book was released on 1998-09-16 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an exceptionally experienced author in the area of medical equipment product design, this text presents a comprehensive overview of such sound principles and state-of-the-art techniques covering a whole host of material types, biocompatability, the design process and future trends within this exciting field. An all-in-one reference text, concise and easy-to-read. Wide audience appeal, from industry professionals to students of design.
Book Synopsis Biomaterials in the Design and Reliability of Medical Devices by : Michael N. Helmus
Download or read book Biomaterials in the Design and Reliability of Medical Devices written by Michael N. Helmus and published by Springer Science & Business Media. This book was released on 2003-01-31 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights the responsibility of medical device designers and engineers to eliminate sites of failure and to test devices to demonstrate their ultimate safety and efficacy. It also evaluates biomaterials and their properties as related to the design and reliability of medical devices. The principles that are described are readily applicable to the biomaterial scaffolds used for generating tissue-engineered constructs.
Book Synopsis Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach by : Frederick Silver
Download or read book Biomaterials, Medical Devices and Tissue Engineering: An Integrated Approach written by Frederick Silver and published by Springer Science & Business Media. This book was released on 1993-11-30 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: are then selected and must meet the general 'biocompatibility' require ments. Prototypes are built and tested to include biocompatibility evalua tions based on ASTM standard procedures. The device is validated for sterility and freedom from pyrogens before it can be tested on animals or humans. Medical devices are classified as class I, II or III depending on their invasiveness. Class I devices can be marketed by submitting notification to the FDA. Class II and III devices require either that they show equivalence to a device marketed prior to 1976 or that they receive pre-marketing approval. The time from device conception to FDA approval can range from months (class I device) to in excess of ten years (class III device). Therefore, much planning is necessary to pick the best regulatory approach. 2. Wound Dressings and Skin Replacement 2.1 Introduction Wounds to the skin are encountered every day. Minor skin wounds cause some pain, but these wounds will heal by themselves in time. Even though many minor wounds heal effectively without scarring in the absence of treatment, they heal more rapidly if they are kept clean and moist. Devices such as Band-Aids are used to assist in wound healing. For deeper wounds, a variety of wound dressings have been developed including cell cultured artificial skin. These materials are intended to promote healing of skin damaged or removed as a result of skin grafting, ulceration, burns, cancer excision or mechanical trauma.
Book Synopsis Metallic Biomaterials Processing and Medical Device Manufacturing by : Cuie Wen
Download or read book Metallic Biomaterials Processing and Medical Device Manufacturing written by Cuie Wen and published by Woodhead Publishing. This book was released on 2020-08-20 with total page 606 pages. Available in PDF, EPUB and Kindle. Book excerpt: Metallic Biomaterials Processing and Medical Device Manufacturing details the principles and practices of the technologies used in biomaterials processing and medical device manufacturing. The book reviews the main categories of metallic biomaterials and the essential considerations in design and manufacturing of medical devices. It bridges the gap between the designing of biomaterials and manufacturing of medical devices including requirements and standards. Main themes of the book include, manufacturing, coatings and surface modifications of medical devices, metallic biomaterials and their mechanical behaviour, degradation, testing and characterization, and quality controls, standards and FDA regulations of medical devices. The leading experts in the filed discuss the requirements, challenges, recent progresses and future research directions in the processing of materials and manufacturing of medical devices. Metallic Biomaterials Processing and Medical Device Manufacturing is ideal for those working in the disciplines of materials science, manufacturing, biomedical engineering, and mechanical engineering. Reviews key topics of biomaterials processing for medical device applications including metallic biomaterials and their mechanical behavior, degradation, testing and characterization Bridges the gap between biomaterials design and medical device manufacturing Discusses the quality controls, standards, and FDA requirements for biomaterials and medical devices
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 709 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
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
Book Synopsis Biomedical Devices by : Raymond H. W. Lam
Download or read book Biomedical Devices written by Raymond H. W. Lam and published by Springer. This book was released on 2019-08-16 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook provides essential knowledge for biomedical product development, including material properties, fabrication processes and design techniques for different applications, as well as process design and optimization. This book is multidisciplinary and readers can learn techniques to apply acquired knowledge for various applications of biomedical design. Further, this book encourages readers to discover and convert newly reported technologies into products and services for the future development of biomedical applications. This is an ideal book for upper-level undergraduate and graduate students, engineers, technologists, and researchers working in the area of biomedical engineering and manufacturing. This book also: Provides a comprehensive set of fundamental knowledge for engineering students and entry level engineers to design biomedical devices Offers a unique approach to manufacturing of biomedical devices by integrating and formulating different considerations in process design tasks into optimization problems Provides a broad range of application examples to guide readers through the thinking process of designing and manufacturing biomedical devices, from basic understanding about the requirements and regulations to a set of manufacturing parameters
Book Synopsis Design of Biomedical Devices and Systems by : Dragan Primorac
Download or read book Design of Biomedical Devices and Systems written by Dragan Primorac and published by CRC Press. This book was released on 2014-07-29 with total page 494 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.
Book Synopsis Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices by : Andrés Díaz Lantada
Download or read book Handbook on Advanced Design and Manufacturing Technologies for Biomedical Devices written by Andrés Díaz Lantada and published by Springer Science & Business Media. This book was released on 2014-07-08 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: The last decades have seen remarkable advances in computer‐aided design, engineering and manufacturing technologies, multi‐variable simulation tools, medical imaging, biomimetic design, rapid prototyping, micro and nanomanufacturing methods and information management resources, all of which provide new horizons for the Biomedical Engineering fields and the Medical Device Industry. Advanced Design and Manufacturing Technologies for Biomedical Devices covers such topics in depth, with an applied perspective and providing several case studies that help to analyze and understand the key factors of the different stages linked to the development of a novel biomedical device, from the conceptual and design steps, to the prototyping and industrialization phases. Main research challenges and future potentials are also discussed, taking into account relevant social demands and a growing market already exceeding billions of dollars. In time, advanced biomedical devices will decisively change methods and results in the medical world, dramatically improving diagnoses and therapies for all kinds of pathologies. But if these biodevices are to fulfill present expectations, today’s engineers need a thorough grounding in related simulation, design and manufacturing technologies, and collaboration between experts of different areas has to be promoted, as is also analyzed within this handbook.
Book Synopsis Medical Device and Equipment Design by : Michael E. Wiklund
Download or read book Medical Device and Equipment Design written by Michael E. Wiklund and published by CRC Press. This book was released on 1995-02-15 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Design Controls for the Medical Device Industry by : Marie B. Teixeira
Download or read book Design Controls for the Medical Device Industry written by Marie B. Teixeira and published by CRC Press. This book was released on 2002-09-20 with total page 253 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 utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.
Book Synopsis Standard Handbook of Biomedical Engineering and Design by : Myer Kutz
Download or read book Standard Handbook of Biomedical Engineering and Design written by Myer Kutz and published by McGraw-Hill Professional Publishing. This book was released on 2003 with total page 1500 pages. Available in PDF, EPUB and Kindle. Book excerpt: THE HANDBOOK THAT BRIDGES THE GAP BETWEEN ENGINEERING PRINCIPLES AND BIOLOGICAL SYSTEMS The focus in the "Standard Handbook of Biomedical Engineering and Design" is on engineering design informed by description and analysis using engineering language and methodology. Over 40 experts from universities and medical centers throughout North America, the United Kingdom, and Israel have produced a practical reference for the biomedical professional who is seeking to solve a wide range of engineering and design problems, whether to enhance a diagnostic or therapeutic technique, reduce the cost of manufacturing a medical instrument or a prosthetic device, improve the daily life of a patient with a disability, or increase the effectiveness of a hospital department. Heavily illustrated with tables, charts, diagrams, and photographs, most of them original, and filled with equations and useful references, this handbook speaks directly to all practitioners involved in biomedical engineering, whatever their training and areas of specialization. Coverage includes not only fundamental principles, but also numerous recent advances in this fast moving discipline. Major sections include: * Biomedical Systems Analysis * Mechanics of the Human Body * Biomaterials * Bioelectricity * Design of Medical Devices and Diagnostic Instrumentation * Engineering Aspects of Surgery * Rehabilitation Engineering * Clinical Engineering The "Handbook" offers breadth and depth of biomedical engineering design coverage unmatched in any other general reference.
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.
Download or read book Biomedical Devices written by Tugrul Özel and published by John Wiley & Sons. This book was released on 2016-10-24 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis The Design and Manufacture of Medical Devices by : J. Paulo Davim
Download or read book The Design and Manufacture of Medical Devices written by J. Paulo Davim and published by Elsevier. This book was released on 2012-10-16 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Regulatory Affairs for Biomaterials and Medical Devices by : Stephen F. Amato
Download or read book Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato and published by Elsevier. This book was released on 2014-10-27 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Download or read book Biomaterials written by Qizhi Chen and published by CRC Press. This book was released on 2014-12-15 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explores Biomedical Science from a Unique Perspective Biomaterials: A Basic Introduction is a definitive resource for students entering biomedical or bioengineering disciplines. This text offers a detailed exploration of engineering and materials science, and examines the boundary and relationship between the two. Based on the author’s course lecture notes and many years of research, it presents students with the knowledge needed to select and design biomaterials used in medical devices. Placing special emphasis on metallic, ceramic, polymeric, and composite biomaterials, it explains the difference between materials science and materials engineering, introduces basic concepts and principles, and analyzes the critically important properties of biomaterials. Explains Complex Theories Using Aspects of Daily Life This text provides an appropriate balance between depth and broadness of coverage, and offers an understanding of the most important concepts and principles to students from a wide academic spectrum. It delivers the science of biomaterials in laymen terms, from a material standpoint, as well as a clinical applications point of view. It equips students majoring in materials science/engineering with knowledge on the fundamentals of how biomaterials behave at a biological level, and provides students majoring in medicine with information that is generally unavailable in traditional medical courses. The authors incorporate learning objectives at the beginning of each chapter, as well as chapter highlights, problems, and exercises at the end of each chapter. In addition, they present objectives, suggested activities, and reference material for further reading. Contains an overview of medical science vis-à-vis materials science, describes anatomy, histology, and cell biology Highlights health issues and diseases where biomaterials can easily find medical applications Presents knowledge of the relationship between the biomaterials and the living body Evaluates medical devices and looks into their respective regulations Biomaterials: A Basic Introduction contains an overview of basic biomaterials and concepts, and is written for upper-division students in the US/Canada, and second-level students in universities worldwide.
