Biomaterials In The Design And Reliability Of Medical Devices

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Biomaterials in the Design and Reliability of Medical Devices

Author : Michael N. Helmus
Publisher : Springer Science & Business Media
ISBN 13 : 9780306476907
Total Pages : 240 pages
Book Rating : 4.4/5 (769 download)

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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.

Reliable Design of Medical Devices

Author : Richard C. Fries
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.

Design of Biomedical Devices and Systems Second edition

Author : Paul H. King
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 Controls for the Medical Device Industry

Author : Marie B. Teixeira
Publisher : CRC Press
ISBN 13 : 0824743555
Total Pages : 253 pages
Book Rating : 4.8/5 (247 download)

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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.

Design of Biomedical Devices and Systems

Author : Dragan Primorac
Publisher : CRC Press
ISBN 13 : 146656914X
Total Pages : 515 pages
Book Rating : 4.4/5 (665 download)

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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 515 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 Engineering of Biomaterials for Medical Devices

Author : David Hill
Publisher :
ISBN 13 :
Total Pages : 468 pages
Book Rating : 4.:/5 (117 download)

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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 . This book was released on 1998 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Durability and Reliability of Medical Polymers

Author : Mike Jenkins
Publisher : Elsevier
ISBN 13 : 0857096516
Total Pages : 293 pages
Book Rating : 4.8/5 (57 download)

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Book Synopsis Durability and Reliability of Medical Polymers by : Mike Jenkins

Download or read book Durability and Reliability of Medical Polymers written by Mike Jenkins and published by Elsevier. This book was released on 2012-08-13 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: Given the widespread use of polymers in medical devices, the durability and reliability of this material in use is an area of critical importance. Durability and reliability of medical polymers reviews the performance of both bioresorbable and non-bioresorbable medical polymers. Part one provides a review of the types and properties of bioresorbable medical polymers. The effect of molecular structure on properties is discussed, along with the processing of bioresorbable and other polymers for medical applications. Transport phenomena and the degradation of bioresorbable medical polymers are reviewed, before an exploration of synthetic bioresorbable polymers and their use in orthopaedic tissue regeneration. Part two goes on to explore the durability and reliability of non-bioresorbable medical polymers, and wear processes in polymer implants and ageing processes of biomedical polymers in the body are discussed in depth, before an investigation into manufacturing defects and the failure of synthetic polymeric medical devices. With its distinguished editors and international team of expert contributors, Durability and reliability of medical polymers is an essential tool for all materials scientists, researchers and engineers involved in the design, development and application of medical polymers, whilst also providing a helpful overview of the subject for biologists, chemist and clinicians. Comprehensively examines the performance of both bioresorbable and non-bioresorbable medical polymers Discusses the processing of bioresorbable and other polymers for medical applications, before reviewing the degradation of bioresorbable medical polymers Explores the durability and reliability of non-bioresorbable medical polymers and discusses wear processes in polymer implants and ageing processes of biomedical polymers in the body

Erythrocyte Engineering for Drug Delivery and Targeting

Author : Mauro Magnani
Publisher : Springer Science & Business Media
ISBN 13 : 9780306476914
Total Pages : 240 pages
Book Rating : 4.4/5 (769 download)

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Book Synopsis Erythrocyte Engineering for Drug Delivery and Targeting by : Mauro Magnani

Download or read book Erythrocyte Engineering for Drug Delivery and Targeting written by Mauro Magnani 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: The International Symposia on Plant Lipids, the 15th of which was held in Okazaki, Japan, in May 12-17, 2002, is held every two years and is the only international meeting in this field. The contributions from the symposium collected in this book represent the most up-to-date research results on plant lipids, including their structure, analysis, biosynthesis, regulation, physiological function, environmental aspects, and biotechnology, obtained world-wide during 2000-2002

Metallic Biomaterials Processing and Medical Device Manufacturing

Author : Cuie Wen
Publisher : Woodhead Publishing
ISBN 13 : 0081029667
Total Pages : 606 pages
Book Rating : 4.0/5 (81 download)

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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

Biocompatibility and Performance of Medical Devices

Author : Jean-Pierre Boutrand
Publisher : Elsevier
ISBN 13 : 0857096451
Total Pages : 557 pages
Book Rating : 4.8/5 (57 download)

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Book Synopsis Biocompatibility and Performance of Medical Devices by : Jean-Pierre Boutrand

Download or read book Biocompatibility and Performance of Medical Devices written by Jean-Pierre Boutrand and published by Elsevier. This book was released on 2012-10-26 with total page 557 pages. Available in PDF, EPUB and Kindle. Book excerpt: Implant and device manufacturers are increasingly facing the challenge of proving that their products are safe and biocompatible, and that they will perform as expected. Biocompatibility and performance of medical devices provides an essential guide to the performance analysis of these vital devices.Part one introduces the key concepts and challenges faced in relation to biocompatibility in medical devices, with consideration of biological safety evaluation planning and biomechanical and biochemical compatibility in innovative biomaterials. Part two goes on to discuss the evaluation and characterisation of biocompatibility in medical devices. Topics covered include material and chemical characterisation, allowable limits for toxic leachables, in vivo and in vitro testing and blood compatibility assessment. Testing and interpreting medical device performance is the focus of part three, with chapters describing preclinical performance studies for bone, dental and soft tissue implants, and mechanical testing of soft and hard tissue implants. Part four provides information on the regulation of medical devices in the European Union, Japan and China, and the book concludes with part five, a review of histopathology principles for biocompatibility and performance studies.With its distinguished editor and international team of expert contributors, Biocompatibility and performance of medical devices is a vital tool for all those involved in the research, design, production and application of medical devices, including research directors, production companies and medical regulatory agencies, as well as industry professionals and academics. Examines the key concepts and challenges faced in relation to biocompatibility in medical devices Discusses evaluation and characterisation issues, including material and chemical characterization, allowable limits for toxic leachables, in vivo and in vitro testing, and blood compatibility assessment Delivers a comprehensive overview of testing and interpreting medical device performance

Reliable Design of Medical Devices, Third Edition

Author : Richard C. Fries
Publisher : CRC Press
ISBN 13 : 1439894914
Total Pages : 505 pages
Book Rating : 4.4/5 (398 download)

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

Download or read book Reliable Design of Medical Devices, Third Edition written by Richard C. Fries and published by CRC Press. This book was released on 2012-09-06 with total page 505 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 Design of Medical Devices, Third Edition shows you how to improve reliability in the design of advanced medical devices. Reliability engineering is an integral part of the product development process and of problem-solving activities related to manufacturing and field failures. Mirroring the typical product development process, the book is organized into seven parts. After an introduction to the basics of reliability engineering and failures, it takes you through the concept, feasibility, design, verification and validation, design transfer and manufacturing, and field activity phases. Topics covered include Six Sigma for design, human factors, safety and risk analysis, and new techniques such as accelerated life testing (ALT) and highly accelerated life testing (HALT). What’s New in This Edition Updates throughout, reflecting changes in the field An updated software development process Updated hardware test procedures A new layout that follows the product development process A list of deliverables needed at the end of each development phase Incorporating reliability engineering as a fundamental design philosophy, this book shares valuable insight from the author’s more than 35 years of experience. A practical guide, it helps you develop a more effective reliability engineering program—contributing to increased profitability, more satisfied customers, and less risk of liability.

Biomedical Devices

Author : Tugrul Özel
Publisher : John Wiley & Sons
ISBN 13 : 1118478924
Total Pages : 212 pages
Book Rating : 4.1/5 (184 download)

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Book Synopsis Biomedical Devices by : Tugrul Özel

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

Medical Devices

Author : Seeram Ramakrishna
Publisher : Woodhead Publishing
ISBN 13 : 0081002912
Total Pages : 256 pages
Book Rating : 4.0/5 (81 download)

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Book Synopsis Medical Devices by : Seeram Ramakrishna

Download or read book Medical Devices written by Seeram Ramakrishna and published by Woodhead Publishing. This book was released on 2015-08-18 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical 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

Biomaterials

Author : Joyce Y. Wong
Publisher : CRC Press
ISBN 13 : 0849378893
Total Pages : 293 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Biomaterials by : Joyce Y. Wong

Download or read book Biomaterials written by Joyce Y. Wong and published by CRC Press. This book was released on 2007-06-07 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: For medical devices that must be placed inside the body, the right choice of material is the most important aspect of design. To ensure such devices are safe, reliable, economical, and biologically and physiologically compatible, the modern biomedical engineer must have a broad knowledge of currently available materials and the properties that affe

Practical Design Control Implementation for Medical Devices

Author : Jose Justiniano
Publisher : CRC Press
ISBN 13 : 9780367395384
Total Pages : 232 pages
Book Rating : 4.3/5 (953 download)

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Book Synopsis Practical Design Control Implementation for Medical Devices by : Jose Justiniano

Download or read book Practical Design Control Implementation for Medical Devices written by Jose Justiniano and published by CRC Press. This book was released on 2019-08-30 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verification, and reliability and design validation.

Design of Biomedical Devices and Systems, 4th edition

Author : Paul H. King
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

Regulatory Affairs for Biomaterials and Medical Devices

Author : Stephen F. Amato
Publisher : Elsevier
ISBN 13 : 0857099205
Total Pages : 202 pages
Book Rating : 4.8/5 (57 download)

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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 202 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