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 : 20. 37 MB
Format : PDF
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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.

Usability Testing Of Medical Devices

Author : Michael E. Wiklund, P.E.
ISBN : 1439811849
Genre : Medical
File Size : 66. 28 MB
Format : PDF, ePub, Docs
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To paraphrase a popular saying, usability testing should be done early and often. However, it doesn’t have to be an onerous process. Informative, practical, and engaging, Usability Testing of Medical Devices provides a simple, easy to implement general understanding of usability testing. It offers a general understanding of usability testing and reviews key concepts, highlighting the challenges of validating that protects against dangerous errors that could lead to patient injury and death. The book has been carefully designed to be concise and visually, easily read in one sitting or perused from one section to another as needed It begins with a review of human factors engineering and how usability testing fits in, and then discusses the government regulations and industry standards that have motivated many medical device manufacturers to conduct usability tests. It then covers the nitty-gritty of planning, conducting, and reporting the results of a usability test, making the process as smooth and painless as possible for the development team, and therefore making the medical devices they develop as safe, effective, and appealing as possible. As you read the book, keep in mind that, like snowflakes, each usability test is unique. And while 100 usability specialists working independently might take 100 different approaches to testing, albeit with considerable methodological overlap, there would also be meaningful differences that the practitioners would energetically defend as the best given the circumstances. To make your testing process easier, the authors, seasoned human factors specialists who have conducted thousands of test sessions involving medical devices used by physicians, nurses, therapists, technicians, and patients, have painstakingly put together an informative, practical, and engaging handbook for conducting usability tests of medical devices.

Design Controls For The Medical Device Industry Second Edition

Author : Marie B. Teixeira
ISBN : 9781466503557
Genre : Medical
File Size : 40. 86 MB
Format : PDF, ePub
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The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company’s design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today’s third-party auditor/investigator expectations and saves you valuable time and money. The author’s continual participation in FDA QSR inspections and Notified Body ISO audits is reflected in updates to all chapters and appendices of the book, now bursting at the seams with: New coverage of ISO 9001 and 13485 design control requirements More real-world examples from the medical device industry Additional detail for greater understanding and clarity Fresh templates for practical implementation Extensive references for further study The book addresses 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.

Handbook Of Medical Device Regulatory Affairs In Asia

Author : Jack Wong
ISBN : 9789814411219
Genre : Medical
File Size : 20. 86 MB
Format : PDF
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Medical device regulation in Asia has gained more importance than ever. Governments and regulatory bodies across the region have put in place new regulatory systems or refined the existing ones. A registered product requires a lot of technical documentation to prove its efficacy, safety, and quality. A smooth and successful registration process demands soft skills for dealing with various key stakeholders in the government, testing centers, and hospitals and among doctors. Handbook of Medical Device Regulatory Affairs in Asia covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. Government bodies, the medical device industry, and academics and students will find this book immensely useful in understanding the global regulatory environment and in their research and development projects.

Medical Device Design

Author : Peter J Ogrodnik
ISBN : 9780123919434
Genre : Technology & Engineering
File Size : 44. 49 MB
Format : PDF
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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

Adhesives Technology For Electronic Applications

Author : James J. Licari
ISBN : 1437778909
Genre : Technology & Engineering
File Size : 45. 96 MB
Format : PDF
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Adhesives are widely used in the manufacture and assembly of electronic circuits and products. Generally, electronics design engineers and manufacturing engineers are not well versed in adhesives, while adhesion chemists have a limited knowledge of electronics. This book bridges these knowledge gaps and is useful to both groups. The book includes chapters covering types of adhesive, the chemistry on which they are based, and their properties, applications, processes, specifications, and reliability. Coverage of toxicity, environmental impacts and the regulatory framework make this book particularly important for engineers and managers alike. The third edition has been updated throughout and includes new sections on nanomaterials, environmental impacts and new environmentally friendly ‘green’ adhesives. Information about regulations and compliance has been brought fully up-to-date. As well as providing full coverage of standard adhesive types, Licari explores the most recent developments in fields such as: • Tamper-proof adhesives for electronic security devices. • Bio-compatible adhesives for implantable medical devices. • Electrically conductive adhesives to replace toxic tin-lead solders in printed circuit assembly – as required by regulatory regimes, e.g. the EU’s Restriction of Hazardous Substances Directive or RoHS (compliance is required for all products placed on the European market). • Nano-fillers in adhesives, used to increase the thermal conductivity of current adhesives for cooling electronic devices. A complete guide for the electronics industry to adhesive types, their properties and applications - this book is an essential reference for a wide range of specialists including electrical engineers, adhesion chemists and other engineering professionals Provides specifications of adhesives for particular uses and outlines the processes for application and curing - coverage that is of particular benefit to design engineers, who are charged with creating the interface between the adhesive material and the microelectronic device Discusses the respective advantages and limitations of different adhesives for a varying applications, thereby addressing reliability issues before they occur and offering useful information to both design engineers and Quality Assurance personnel

Design Of Medical Electronic Devices

Author : Reinaldo Perez
ISBN : 0125507119
Genre : Medical
File Size : 54. 68 MB
Format : PDF, Mobi
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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

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