reliable design of medical devices third edition

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Reliable Design Of Medical Devices Third Edition

Author : Richard C. Fries
ISBN : 9781439894941
Genre : Medical
File Size : 38. 75 MB
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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.

Design Of Biomedical Devices And Systems Third Edition

Author : Paul H. King
ISBN : 9781466569133
Genre : Medical
File Size : 32. 82 MB
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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.

Medical Device Design

Author : Peter J Ogrodnik
ISBN : 9780123919434
Genre : Technology & Engineering
File Size : 58. 33 MB
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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

Usability Testing Of Medical Devices Second Edition

Author : Michael E. Wiklund, P.E.
ISBN : 9781466595897
Genre : Medical
File Size : 44. 52 MB
Format : PDF
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Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests. Since publication of the first edition, the FDA and other regulatory groups have modified their regulations and expectations regarding how medical device manufacturers should approach usability testing. Reflecting these changes, this Second Edition provides updated guidance to readers with an interest or direct role in conducting a usability test of a medical device or system. Key updates involve the 2011 FDA guidance on human factors engineering, requirements set forth by the third edition of IEC 60601 and closely related IEC 62366-1:2015, linking usability test tasks to risk analysis results, and analyzing root causes of use errors that occur during usability tests. Written by seasoned human factors specialists, Usability Testing of Medical Devices, Second Edition is an informative, practical, and up-to-date handbook for conducting usability tests of medical devices. The book helps ensure a smooth and painless development process—and thus, safe and effective medical devices.

Design Of Medical Electronic Devices

Author : Reinaldo Perez
ISBN : 9780080491097
Genre : Technology & Engineering
File Size : 25. 93 MB
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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

Applied Reliability Third Edition

Author : Paul A. Tobias
ISBN : 0442004699
Genre : Business & Economics
File Size : 35. 15 MB
Format : PDF, Mobi
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With over 170 pages of new material, the second edition of this widely used reference provides engineers and statisticians with an updated, easy-to-follow approach to evaluating and projecting component and system reliability by combining standard statistical methods with advanced leading-edge reliability techniques. It includes an extensive treatment of life distribution and accelerated testing models and data analysis and data simulation techniques, as well as quality control methods and algorithms used to predict component and assembly field reliability. The second edition includes three completely new chapters: two cover "Repairable System Reliability" (both for renewal and non-renewal models), with an emphasis on simple graphical techniques, while also describing analytical methods for reparable system data analysis. A third new chapter surveys areas such as reliability growth modeling, Bayesian reliability analysis, and field reliability monitoring programs. In addition, this latest edition offers hundreds of new examples, exercises, problems, and references-all designed to provide readers with additional support in understanding and applying the latest reliability testing methods. In bringing state-of-the-art techniques down to an accessible, how-to level, the second edition of Applied Reliability will serve the practical needs of electronic, mechanical, and industrial engineers involved in the design and manufacture of components and systems, and of statisticians and scientists working on applied reliability problems. It will also be a highly suitable textbook for engineering courses in applied reliability and quality control.

Biomaterials

Author : Joon Park
ISBN : 9780387378800
Genre : Technology & Engineering
File Size : 29. 83 MB
Format : PDF
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With sixty years of combined experience, the authors of this extensively revised book have learned to emphasize the fundamental materials science, structure-property relationships, and biological responses as a foundation for a wide array of biomaterials applications. This edition includes a new chapter on tissue engineering and regenerative medicine, approximately 1900 references to additional reading, extensive tutorial materials on new developments in spinal implants and fixation techniques and theory. It also offers systematic coverage of orthopedic implants, and expanded treatment of ceramic materials and implants.

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