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| Author | : Rajkumar Velu |
| Publisher | : Springer Nature |
| Total Pages | : 255 |
| Release | : |
| Genre | : |
| ISBN | : 9819971004 |
| Author | : J. Paulo Davim |
| Publisher | : Elsevier |
| Total Pages | : 382 |
| Release | : 2012-10-16 |
| Genre | : Technology & Engineering |
| ISBN | : 1908818182 |
Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Directive 2007/47/EC defines a medical device as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. The design and manufacture of medical devices brings together a range of articles and case studies dealing with medical device R&D. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. Contains articles on a diverse range of subjects within the field, with internationally renowned specialists discussing each medical device Offers a practical approach to recent developments in the design and manufacture of medical devices Presents a topic that is the focus of research in many important universities and centres of research worldwide
| Author | : Paul H. King |
| Publisher | : CRC Press |
| Total Pages | : 424 |
| Release | : 2008-08-22 |
| Genre | : Medical |
| ISBN | : 1439878072 |
The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This
| Author | : Richard C. Fries |
| Publisher | : CRC Press |
| Total Pages | : 490 |
| Release | : 2005-11-21 |
| Genre | : Medical |
| ISBN | : 1420027948 |
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.
| Author | : Tugrul Özel |
| Publisher | : John Wiley & Sons |
| Total Pages | : 212 |
| Release | : 2016-10-24 |
| Genre | : Science |
| ISBN | : 1118478924 |
Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source
| Author | : Marie B. Teixeira |
| Publisher | : CRC Press |
| Total Pages | : 253 |
| Release | : 2002-09-20 |
| Genre | : Medical |
| ISBN | : 0824743555 |
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 utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. Design Controls for the Medical Device Industry contains valuable guidelines that enable readers to prepare for an FDA audit identify consumer needs, resolve project objectives, and process inconsistencies and discrepancies determine the compatibility of design specifications and manufacturing, installation, and servicing demands ensure that proper design, function, and performance stipulations are understood and met verify and validate design criteria and production schemes eliminate confusion and prevent communication breakdowns allocate and conserve resources perform risk assessment analyses predict potential hazards under normal and fault conditions Presenting blueprints for the application, evaluation, and refinement of quality assurance and performance practices-from product launch through engineering and assembly-Design Controls for the Medical Device Industry is a clear and indispensable source for biomedical, quality assurance, reliability, software, product design, manufacturing, research and development, and industrial engineers; project directors and managers; biomedical technicians; and upper-level undergraduate and graduate students in these disciplines.
| Author | : Paul H. King |
| Publisher | : CRC Press |
| Total Pages | : 725 |
| Release | : 2018-10-03 |
| Genre | : Medical |
| ISBN | : 0429786050 |
This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes
| Author | : Peter J. Ogrodnik |
| Publisher | : Academic Press |
| Total Pages | : 538 |
| Release | : 2019-10-30 |
| Genre | : Technology & Engineering |
| ISBN | : 0128149639 |
Medical Device Design: Innovation from Concept to Market, Second Edition 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; this book fills that need. It addresses medical devices' regulatory (FDA and EU) requirements, shows the essential methodologies medical designers must understand to ensure their products meet requirements, and brings together proven design protocols, thus enabling engineers and medical device manufacturers to rapidly bring new products to the marketplace. This book is unique because it takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. This rare resource can be used by both professionals and newcomers to device design. Provides a reference to standards and regulations that have been updated, including ISO 13485:2016, FDA regulations and the European Medical Device Regulation Includes new case studies in the areas of classifying medical devices, the design process, quality, labeling, instructions for use, and more Presents additional content around software and biocompatibility concerns
| Author | : Jose Justiniano |
| Publisher | : CRC Press |
| Total Pages | : 152 |
| Release | : 2004-11-15 |
| Genre | : Science |
| ISBN | : 0203485742 |
For designers of medical devices, the FDA and ISO requirements are extremely stringent. Designers and researchers feel pressure from management to quickly develop new devices, while they are simultaneously hampered by strict guidelines. The Six Sigma philosophy has solved this dichotomous paradigm for organizations in other fields, and seeks to do
| Author | : Gail Baura |
| Publisher | : Academic Press |
| Total Pages | : 0 |
| Release | : 2020-11-24 |
| Genre | : Science |
| ISBN | : 0128119853 |
Medical Device Technologies: A Systems Based Overview Using Engineering Standards, Second Edition, is a comprehensive overview of medical device technology, with a unified approach to each device area covering technical operation, clinical need, regulatory issues and standards and historical devices. It takes a systems-based view, balancing breadth with depth to give an accessible introduction to this field. Close ties are drawn between the design, the product and the patient. Exercises at the end of each chapter include traditional homework problems, analysis exercises and four questions from assigned primary literature. Eight laboratory experiments in both electrical and mechanical medical devices are explored. 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. This systems approach enables the reader to quickly identify the relationships between devices. Covers current research, design issues and engineering standards Includes three significant Food and Drug Administration (FDA) recall case studies which have impacted FDA medical device regulation Presents exercises at the end of each chapter, including problems, analysis exercises and four questions from assigned primary literature Provides eight laboratory experiments that are detailed to provide hands-on reinforcement of device concepts
