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Author: Theodore R. Kucklick
Publisher: CRC Press
Published: 2005-11-21
Total Pages: 376
ISBN-13: 1420038354
DOWNLOAD EBOOKThe 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
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Publisher: Academic Press
Published: 2012-12-17
Total Pages: 369
ISBN-13: 0123919436
DOWNLOAD EBOOKThis 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
Author: William Durfee
Publisher: Lulu.com
Published: 2014-03-23
Total Pages: 148
ISBN-13: 132902995X
DOWNLOAD EBOOKA short handbook for the medical device innovator who wishes to understand the innovation process for new medical devices.
Author: Stefanos Zenios
Publisher: Cambridge University Press
Published: 2010
Total Pages: 779
ISBN-13: 0521517427
DOWNLOAD EBOOKRecognize 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.
Author: Jack Wong
Publisher: CRC Press
Published: 2022-01-27
Total Pages: 806
ISBN-13: 1000440516
DOWNLOAD EBOOKThis 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. Experts from influential international regulatory bodies, including the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency, Japan Pharmaceuticals and Medical Devices Agency, Saudi Food and Drug Authority, Korea Testing Laboratory, Taiwan FDA, World Health Organization, Asian Harmonization Working Party, Regulatory Affairs Professionals Society, and British Standards Institution, have contributed to the book. Government bodies, the medical device industry, academics, students, and general readers will find the book immensely useful for understanding the global regulatory environment and in their research and development projects.
Author: I. Glenn Cohen
Publisher: Cambridge University Press
Published: 2022-04-07
Total Pages: 295
ISBN-13: 1108838634
DOWNLOAD EBOOKA detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.
Author: Mark Dodgson
Publisher:
Published: 2014
Total Pages: 722
ISBN-13: 019969494X
DOWNLOAD EBOOKWhile innovation is widely recognised as being critical to organisational success and the well-being of societies, it requires careful management to ensure that innovation processes have the best possible impact. This volume provides a wide range of perspectives on the nature of innovation management and its influences.
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Publisher: ASM International
Published: 2009-01-01
Total Pages: 453
ISBN-13: 1615031359
DOWNLOAD EBOOK"The Materials Information Society, MPMD-Materials and Processes for Medical Devices."
Author: Patrick Kullmann
Publisher: Two Harbors Press
Published: 2012
Total Pages: 90
ISBN-13: 9781937293857
DOWNLOAD EBOOK"The Inventor's Guide for Medical Technology: From Your Napkin to the Market--What Innovators Need to Know" offers a series of clearly defined steps, guiding inventors in the process of taking their idea "from concept to market." In chapters such as "The Invention," "Research and Development," "Manufacturing," “Finance and Accounting,” “Launching in the U.S.” and “The Exit,” Paul Kullmann discusses trademarks and patents, clinical trial designs, funding, choosing the right team, and so much more. Each chapter ends with a tidbit of personal advice, based on Kullmann's insight and indisputably expert knowledge. With Kullmann's guidance, inventors and entrepreneurs alike can sidestep the pitfalls and increase their probability of success. See the free tool library information available inside the book. With his over twenty-eight years in the medical technology field and a long history as an entrepreneur, speaker, educator, and angel investor, Patrick Kullmann is the voice of experience.
Author: Gail D. Baura
Publisher: Academic Press
Published: 2011-10-07
Total Pages: 529
ISBN-13: 012374976X
DOWNLOAD EBOOKMedical Device Technologies introduces undergraduate engineering students 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 eight chapters focus on medical device laboratory experiments. 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 lets students 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). 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
