The Medical Device R D Handbook Book

The Medical Device R D Handbook


  • Author : Theodore R. Kucklick
  • Publisher : CRC Press
  • Release Date : 2005-11-21
  • Genre: Medical
  • Pages : 376
  • ISBN 10 : 9781420038354

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The Medical Device R D Handbook Excerpt :

The Medical Device R&D Handbook presents a wealth of information for the hands-on design and building of medical devices. Detailed information on such diverse topics as catheter building, prototyping, materials, processes, regulatory issues, and much more are available in this convenient handbook for the first time. The Medical Device R&D Ha

The Medical Device R D Handbook  Second Edition Book

The Medical Device R D Handbook Second Edition


  • Author : Theodore R. Kucklick
  • Publisher : CRC Press
  • Release Date : 2012-12-05
  • Genre: Medical
  • Pages : 510
  • ISBN 10 : 9781439811894

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The Medical Device R D Handbook Second Edition Excerpt :

Exploring the practical, entrepreneurial, and historical aspects of medical device development, this second edition of The Medical Device R&D Handbook provides a how-to guide for medical device product development. The book offers knowledge of practical skills such as prototyping, plastics selection, and catheter construction, allowing designers to apply these specialized techniques for greater innovation and time saving. The author discusses the historical background of various technologies, helping readers understand how and why certain devices were developed. The text also contains interviews with leaders in the industry who offer their vast experience and insights on how to start and grow successful companies—both what works and what doesn’t work. This updated and expanded edition adds new information to help meet the challenges of the medical device industry, including strategic intellectual property management, operating room observation protocol, and the use of new technologies and new materials in device development.

Medical Device Technologies Book

Medical Device Technologies


  • Author : Gail D. Baura
  • Publisher : Academic Press
  • Release Date : 2012
  • Genre: Science
  • Pages : 512
  • ISBN 10 : 9780123749765

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Medical Device Technologies Excerpt :

The goal of this textbook is to provide undergraduate engineering students with an introduction 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 8 chapters are medical device laboratory experiment chapters. 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 enables students to 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). Key Features: 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

Clinical Engineering Handbook Book

Clinical Engineering Handbook


  • Author : Ernesto Iadanza
  • Publisher : Academic Press
  • Release Date : 2019-12-06
  • Genre: Technology & Engineering
  • Pages : 958
  • ISBN 10 : 9780128134689

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Clinical Engineering Handbook Excerpt :

Clinical Engineering Handbook, Second Edition, covers modern clinical engineering topics, giving experienced professionals the necessary skills and knowledge for this fast-evolving field. Featuring insights from leading international experts, this book presents traditional practices, such as healthcare technology management, medical device service, and technology application. In addition, readers will find valuable information on the newest research and groundbreaking developments in clinical engineering, such as health technology assessment, disaster preparedness, decision support systems, mobile medicine, and prospects and guidelines on the future of clinical engineering. As the biomedical engineering field expands throughout the world, clinical engineers play an increasingly important role as translators between the medical, engineering and business professions. In addition, they influence procedures and policies at research facilities, universities, and in private and government agencies. This book explores their current and continuing reach and its importance. Presents a definitive, comprehensive, and up-to-date resource on clinical engineering Written by worldwide experts with ties to IFMBE, IUPESM, Global CE Advisory Board, IEEE, ACCE, and more Includes coverage of new topics, such as Health Technology Assessment (HTA), Decision Support Systems (DSS), Mobile Apps, Success Stories in Clinical Engineering, and Human Factors Engineering

Handbook of Medical Device Regulatory Affairs in Asia Book

Handbook of Medical Device Regulatory Affairs in Asia


  • Author : Jack Wong
  • Publisher : CRC Press
  • Release Date : 2018-03-28
  • Genre: Medical
  • Pages : 620
  • ISBN 10 : 9780429996771

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Handbook of Medical Device Regulatory Affairs in Asia Excerpt :

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. This handbook covers medical device regulatory systems in different countries, ISO standards for medical devices, clinical trial and regulatory requirements, and documentation for application. It is the first to cover the medical device regulatory affairs in Asia. Each chapter provides substantial background materials relevant to the particular area to have a better understanding of regulatory affairs.

Medical Device Design Book

Medical Device Design


  • Author : Peter J Ogrodnik
  • Publisher : Academic Press
  • Release Date : 2012-12-17
  • Genre: Technology & Engineering
  • Pages : 376
  • ISBN 10 : 9780123919434

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Medical Device Design Excerpt :

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 Book

Usability Testing of Medical Devices


  • Author : Michael E. Wiklund P.E.
  • Publisher : CRC Press
  • Release Date : 2015-12-23
  • Genre: Medical
  • Pages : 477
  • ISBN 10 : 9781466595897

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Usability Testing of Medical Devices Excerpt :

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 h

The Medical Device Validation Handbook Book

The Medical Device Validation Handbook


  • Author : Robert Packard
  • Publisher : Unknown
  • Release Date : 2015-04-05
  • Genre: Uncategoriezed
  • Pages : 258
  • ISBN 10 : 0967311527

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The Medical Device Validation Handbook Excerpt :

Reference text on validation processes for manufacturing medical devices.

Safety Risk Management for Medical Devices Book

Safety Risk Management for Medical Devices


  • Author : Bijan Elahi
  • Publisher : Academic Press
  • Release Date : 2021-11-11
  • Genre: Technology & Engineering
  • Pages : 534
  • ISBN 10 : 9780323918237

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Safety Risk Management for Medical Devices Excerpt :

Safety Risk Management for Medical Devices, Second Edition teaches the essential safety risk management methodologies for medical devices compliant with the requirements of ISO 14971:2019. Focusing exclusively on safety risk assessment practices required in the MedTech sector, the book outlines sensible, easily comprehensible, state-of the-art methodologies that are rooted in current industry best practices, addressing safety risk management of medical devices, thus making it useful for those in the MedTech sector who are responsible for safety risk management or need to understand risk management, including design engineers, product engineers, development engineers, software engineers, Quality assurance and regulatory affairs. Graduate-level engineering students with an interest in medical devices will also benefit from this book. The new edition has been fully updated to reflect the state-of-the-art in this fast changing field. It offers guidance on developing and commercializing medical devices in line with the most current international standards and regulations. Includes new coverage of ISO 14971:2019, ISO/TR 24971 Presents the latest information on the history of risk management, lifetime of a medical device, risk management review, production and post production activities, post market risk management Provides practical, easy-to-understand and state-of the-art methodologies that meet the requirements of international regulation

Plastics in Medical Devices Book

Plastics in Medical Devices


  • Author : Vinny R. Sastri
  • Publisher : Elsevier
  • Release Date : 2010-03-05
  • Genre: Technology & Engineering
  • Pages : 352
  • ISBN 10 : 9780815520283

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Plastics in Medical Devices Excerpt :

No book has been published that gives a detailed description of all the types of plastic materials used in medical devices, the unique requirements that the materials need to comply with and the ways standard plastics can be modified to meet such needs. This book will start with an introduction to medical devices, their classification and some of the regulations (both US and global) that affect their design, production and sale. A couple of chapters will focus on all the requirements that plastics need to meet for medical device applications. The subsequent chapters describe the various types of plastic materials, their properties profiles, the advantages and disadvantages for medical device applications, the techniques by which their properties can be enhanced, and real-world examples of their use. Comparative tables will allow readers to find the right classes of materials suitable for their applications or new product development needs.

Medical Device Packaging Handbook  Revised and Expanded Book
Score: 4
From 3 Ratings

Medical Device Packaging Handbook Revised and Expanded


  • Author : Max Sherman
  • Publisher : CRC Press
  • Release Date : 1998-08-25
  • Genre: Medical
  • Pages : 416
  • ISBN 10 : 0849384494

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Medical Device Packaging Handbook Revised and Expanded Excerpt :

This volume details current developments in industry practices and standards relating to medical device packaging. This edition offers entirely new as well as revised chapters on packaging materials, package validation and methods and integrity testing, bar-coding technology, environmentally sound packaging and disposal procedures, storage autoclav

Design Controls for the Medical Device Industry Book

Design Controls for the Medical Device Industry


  • Author : Marie Teixeira
  • Publisher : CRC Press
  • Release Date : 2002-09-20
  • Genre: Medical
  • Pages : 254
  • ISBN 10 : 0203909380

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Design Controls for the Medical Device Industry 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 utilize

Biodesign Book
Score: 5
From 2 Ratings

Biodesign


  • Author : Stefanos Zenios
  • Publisher : Cambridge University Press
  • Release Date : 2010
  • Genre: Medical
  • Pages : 742
  • ISBN 10 : 9780521517423

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Biodesign Excerpt :

Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals.

Biocompatibility and Performance of Medical Devices Book

Biocompatibility and Performance of Medical Devices


  • Author : Jean-Pierre Boutrand
  • Publisher : Woodhead Publishing
  • Release Date : 2019-11-21
  • Genre: Medical
  • Pages : 586
  • ISBN 10 : 9780081026441

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Biocompatibility and Performance of Medical Devices Excerpt :

Biocompatibility and Performance of Medical Devices, Second Edition, provides an understanding of the biocompatibility and performance tests for ensuring that biomaterials and medical devices are safe and will perform as expected in the biological environment. Sections cover key concepts and challenges faced in relation to biocompatibility in medical devices, discuss the evaluation and characterization of biocompatibility in medical devices, describe preclinical performance studies for bone, dental and soft tissue implants, and provide information on the regulation of medical devices in the European Union, Japan and China. The book concludes with a review of histopathology principles for biocompatibility and performance studies. Presents diverse insights from experts in government, industry and academia Delivers a comprehensive overview of testing and interpreting medical device performance Expanded to include new information, including sections on managing extractables, accelerating and simplifying medical device development through screening and alternative biocompatibility methods, and quality strategies which fasten device access to market

Reliable Design of Medical Devices Book

Reliable Design of Medical Devices


  • Author : Richard C. Fries
  • Publisher : CRC Press
  • Release Date : 2005-11-21
  • Genre: Medical
  • Pages : 504
  • ISBN 10 : 9781420027945

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Reliable Design of Medical Devices 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.