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The Medical Device R D Handbook Second Edition

The Medical Device R D Handbook  Second Edition Author Theodore R. Kucklick
ISBN-10 9781439811894
Release 2012-12-05
Pages 510
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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.



The Medical Device R D Handbook

The Medical Device R D Handbook Author Theodore R. Kucklick
ISBN-10 9781420038354
Release 2005-11-21
Pages 376
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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 Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that are critical to the medical device entrepreneur. Highlights Include... An Introduction to Medical Plastics Catheter Forming Equipment and Operations Basics of Catheter Construction Basics of Medical Needles Rapid Prototyping for Medical Devices Reverse Engineering for Medical Devices Using Medical Illustration in Product Development Introduction to Pre-Clinical Studies Introduction to Regulatory Affairs Assessing Biocompatibility Exclusive Interviews with Key Industry Leaders ...And More This practical handbook is a unique, insightful guide that helps you design, test, and successfully introduce new medical devices to the marketplace.



Handbook of Medical Device Regulatory Affairs in Asia

Handbook of Medical Device Regulatory Affairs in Asia Author Jack Wong
ISBN-10 9780429996764
Release 2018-03-28
Pages 620
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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. 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 Packaging Handbook Second Edition Revised and Expanded

Medical Device Packaging Handbook  Second Edition  Revised and Expanded Author Max Sherman
ISBN-10 0824701992
Release 1998-08-25
Pages 416
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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 autoclave sytems, international standards, customer needs, regulatory aspects, and more.



Handbook of Human Factors in Medical Device Design

Handbook of Human Factors in Medical Device Design Author Matthew Bret Weinger
ISBN-10 1420063510
Release 2010-12-13
Pages 844
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Developed to promote the design of safe, effective, and usable medical devices, Handbook of Human Factors in Medical Device Design provides a single convenient source of authoritative information to support evidence-based design and evaluation of medical device user interfaces using rigorous human factors engineering principles. It offers guidance on user-centric design supported by discussions of design issues, case studies, and examples. The book sets the foundation with coverage of fundamental topics such as aligning the interactive nature of medical devices to the expected use environments ranging from hospitals and ambulances to patients’ homes, drawing on anthropometric and biomechanical data to ensure that designs match the intended users’ bodies and physical abilities, and conducting usability tests and other evaluations to ensure that devices perform as intended. It then focuses on applied design issues, offering guidance on the design of specific types of devices and designing devices for particular use environments. Adapted in part from established design standards and conventions, the design guidance presented in this work distills professional judgment extracted from the contributing authors’ years of experience in applied analysis and design. Written in true handbook style, each chapter stands alone and includes tables, illustrations, and cross references, allowing you to quickly find the exact information you need. Most chapters begin with a general introduction to the selected topic, followed by the presentation of general and special design considerations and then specific, numbered design guidelines. The book also presents a listing of resources, literature, and website references. It not only focuses on the human factors issues that arise when developing medical devices, it supplies the necessary guidance to resolve them.



Usability Testing of Medical Devices Second Edition

Usability Testing of Medical Devices  Second Edition Author Michael E. Wiklund, P.E.
ISBN-10 9781466595897
Release 2015-12-23
Pages 455
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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.



Medical Device Packaging Handbook Second Edition Revised and Expanded

Medical Device Packaging Handbook  Second Edition  Revised and Expanded Author Max Sherman
ISBN-10 0849384494
Release 1998-08-25
Pages 416
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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 autoclave sytems, international standards, customer needs, regulatory aspects, and more.



UHMWPE Biomaterials Handbook

UHMWPE Biomaterials Handbook Author Steven M. Kurtz
ISBN-10 9780323354356
Release 2015-09-16
Pages 840
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UHMWPE Biomaterials Handbook, Third Edition, describes the science, development, properties, and application of ultra-high molecular weight polyethylene (UHMWPE) used in artificial joints. UHMWPE is now the material of choice for joint replacements, and is increasingly being used in fibers for sutures. This book is a one-stop reference for information on this advanced material, covering both introductory topics and the most advanced developments. The third edition adds six new chapters on a range of topics, including the latest in anti-oxidant technologies for stabilizing HXLPE and up-to-date systematic reviews of the clinical literature for HXLPE in hips and knees. The book chronicles the rise and fall of all-metal hip implants, as well as the increased use of ceramic biomaterials and UHMWPE for this application. This book also brings orthopedic researchers and practitioners up to date on the stabilization of UHMWPE with antioxidants, as well as the choices of antioxidant available for practitioners. The book also thoroughly assesses the clinical performance of HXLPE, as well as alternative bearings in knee replacement and UHMWPE articulations with polyether ether ketone (PEEK). Written and edited by the top experts in the field of UHMWPE, this is the only state-of-the-art reference for professionals, researchers, and clinicians working with this material. The only complete reference for professionals, researchers, and clinicians working with ultra-high molecular weight polyethylene biomaterials technologies for joint replacement and implants New edition includes six new chapters on a wide range of topics, including the clinical performance of highly crosslinked polyethylene (HXLPE) in hip and knee replacement, an overview of antioxidant stabilization for UHMWPE, and the medical applications of UHMWPE fibers State-of-the-art coverage of the latest UHMWPE technology, orthopedic applications, biomaterial characterization, and engineering aspects from recognized leaders in the field



The Biomedical Quality Auditor Handbook Second Edition

The Biomedical Quality Auditor Handbook  Second Edition Author ASQ Biomedical Division
ISBN-10 9780873898362
Release 2012-11-19
Pages 296
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This handbook serves as a reference source for the application of quality auditing principles to the biomedical industry, including coverage specifically pertaining to medical devices. The book focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing, and includes information on related regulations, directives, standards, and guidance. The book covers a wide range of subjects that have specific interpretations unique to the biomedical industry. In addition to being a peerless reference for ASQ's Biomedical Auditor certification (CBA), this book is a valuable reference for biomedical professionals who want to execute better audits for medical devices and gain basic knowledge of biomedical technical areas and regulatory requirements.



Handbook of Materials for Medical Devices

Handbook of Materials for Medical Devices Author Joseph R. Davis
ISBN-10 UOM:39015057642228
Release 2003-01-01
Pages 341
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ASM International has been documenting the properties and failure mechanics, of metallic implant materials for the past 20 years, but mostly in the form of reviews in various volumes of the Metals/ASM Handbook series. Here staff members compile the information (not the original articles) into a sing



The Medical Device Validation Handbook

The Medical Device Validation Handbook Author Robert Packard
ISBN-10 0967311527
Release 2015-04-05
Pages 258
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Reference text on validation processes for manufacturing medical devices.



The Medical Device R D Handbook

The Medical Device R D Handbook Author Theodore R. Kucklick
ISBN-10 9781420038354
Release 2005-11-21
Pages 376
Download Link Click Here

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 Handbook also includes exclusive interviews with pioneers and leaders in the medical device industry, offering an insider's perspective on issues that are critical to the medical device entrepreneur. Highlights Include... An Introduction to Medical Plastics Catheter Forming Equipment and Operations Basics of Catheter Construction Basics of Medical Needles Rapid Prototyping for Medical Devices Reverse Engineering for Medical Devices Using Medical Illustration in Product Development Introduction to Pre-Clinical Studies Introduction to Regulatory Affairs Assessing Biocompatibility Exclusive Interviews with Key Industry Leaders ...And More This practical handbook is a unique, insightful guide that helps you design, test, and successfully introduce new medical devices to the marketplace.



Contextual Inquiry for Medical Device Design

Contextual Inquiry for Medical Device Design Author Mary Beth Privitera
ISBN-10 9780128018743
Release 2015-05-29
Pages 310
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Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technology Helps users understand the everyday use of medical devices and the way their usage supports the development of better products Includes case studies that provide a frame of reference on how contextual inquiry is successfully used during the product design process



Clinical Engineering Handbook

Clinical Engineering Handbook Author Joseph F. Dyro
ISBN-10 9780122265709
Release 2004
Pages 674
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Author Joseph Dyro has been awarded the Association for the Advancement of Medical Instrumentation (AAMI) Clinical/Biomedical Engineering Achievement Award which recognizes individual excellence and achievement in the clinical engineering and biomedical engineering fields. He has also been awarded the American College of Clinical Engineering 2005 Tom O'Dea Advocacy Award. As the biomedical engineering field expands throughout the world, clinical engineers play an evermore important role as the translator between the worlds of the medical, engineering, and business professionals. They influence procedure and policy at research facilities, universities and private and government agencies including the Food and Drug Administration and the World Health Organization. Clinical Engineers were key players in calming the hysteria over electrical safety in the 1970's and Y2K at the turn of the century and continue to work for medical safety. This title brings together all the important aspects of Clinical Engineering. It provides the reader with prospects for the future of clinical engineering as well as guidelines and standards for best practice around the world. * Clinical Engineers are the safety and quality faciltators in all medical facilities.



Plastics in Medical Devices

Plastics in Medical Devices Author Vinny R. Sastri
ISBN-10 9780323265638
Release 2013-11-27
Pages 336
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Plastics in Medical Devices is a comprehensive overview of the main types of plastics used in medical device applications. It focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers, and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. Since the first edition the rate of advancement of materials technology has been constantly increasing. In the new edition Dr. Sastri not only provides a thorough update of the first edition chapters with new information regarding new plastic materials, applications and new requirements, but also adds two chapters – one on market and regulatory aspects and supplier controls, and one on process validation. Both chapters meet an urgent need in the industry and make the book an all-encompassing reference not found anywhere else. Comprehensive coverage of uses of polymers for medical devices. Unique coverage of medical device regulatory aspects, supplier control and process validation. Invaluable guide for engineers, scientists and managers involved in the development and marketing of medical devices and materials for use in medical devices.



Biodesign

Biodesign Author Stefanos Zenios
ISBN-10 9780521517423
Release 2010
Pages 742
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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.



Handbook of Polymer Applications in Medicine and Medical Devices

Handbook of Polymer Applications in Medicine and Medical Devices Author Kayvon Modjarrad
ISBN-10 9780323221696
Release 2013-12-05
Pages 368
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While the prevalence of plastics and elastomers in medical devices is now quite well known, there is less information available covering the use of medical devices and the applications of polymers beyond medical devices, such as in hydrogels, biopolymers and silicones beyond enhancement applications, and few books in which these are combined into a single reference. This book is a comprehensive reference source, bringing together a number of key medical polymer topics in one place for a broad audience of engineers and scientists, especially those currently developing new medical devices or seeking more information about current and future applications. In addition to a broad range of applications, the book also covers clinical outcomes and complications arising from the use of the polymers in the body, giving engineers a vital insight into the real world implications of the devices they’re creating. Regulatory issues are also covered in detail. The book also presents the latest developments on the use of polymers in medicine and development of nano-scale devices. Gathers discussions of a large number of applications of polymers in medicine in one place Provides an insight into both the legal and clinical implications of device design Relevant to industry, academic and medical professionals Presents the latest developments in the field, including medical devices on a nano-scale