Download or read book Medical Device Design written by Peter J. Ogrodnik and published by Academic Press. This book was released on 2019-10-30 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Design Dossier written by Pamela Pease and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: An introduction to design providing an overview to different aspects of design as well as the core fundamentals of the art.
Download or read book Applied Mechanical Design written by Ammar Grous and published by John Wiley & Sons. This book was released on 2018-07-02 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is the result of lessons, tutorials and other laboratories dealing with applied mechanical design in the universities and colleges. In the classical literature of the mechanical design, there are quite a few books that deal directly and theory and case studies, with their solutions. All schools, engineering colleges (technical) industrial and research laboratories and design offices serve design works. However, the books on the market remain tight in the sense that they are often works of mechanical constructions. This is certainly beneficial to the ordinary user, but the organizational part of the functional specification items is also indispensable.
Download or read book Handbook of Medical Device Design written by Richard C. Fries and published by CRC Press. This book was released on 2019-08-15 with total page 491 pages. Available in PDF, EPUB and Kindle. Book excerpt: First published in 2001: This handbook has been written to give those professionals working in the development and use of medical devices practical knowledge about biomedical technology, regulations, and their relationship to quality health care.
Download or read book Design Culture written by Guy Julier and published by Bloomsbury Publishing. This book was released on 2019-02-21 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Design culture foregrounds the relationships between the domains of design practice, design production and everyday life. Unlike design history and design studies, it is primarily concerned with contemporary design objects and the networks between the multiple actors engaged in their shaping, functioning and reproduction. It acknowledges the rise of design as both a key component and a key challenge of the modern world. Featuring an impressive range of international case studies, Design Culture interrogates what this emergent discipline is, its methodologies, its scope and its relationships with other fields of study. The volume's interdisciplinary approach brings fresh thinking to this fast-evolving field of study.
Download or read book Combination Products written by Smita Gopalaswamy and published by CRC Press. This book was released on 2008-04-22 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of combination product development (products born of the integration of medical devices, biologics, and drugs) is so new that, while literature abounds on each part individually, there are very few publications, including FDA documents, available concerning the unique challenges posed by this nascent but fast-growing area. Providing
Download or read book Reliable Design of Medical Devices Third Edition written by Richard C. Fries and published by CRC Press. This book was released on 2012-09-06 with total page 505 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Medical Instrument Design and Development written by Claudio Becchetti and published by John Wiley & Sons. This book was released on 2013-07-29 with total page 612 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains all of the stages involved in developing medical devices; from concept to medical approval including system engineering, bioinstrumentation design, signal processing, electronics, software and ICT with Cloud and e-Health development. Medical Instrument Design and Development offers a comprehensive theoretical background with extensive use of diagrams, graphics and tables (around 400 throughout the book). The book explains how the theory is translated into industrial medical products using a market-sold Electrocardiograph disclosed in its design by the Gamma Cardio Soft manufacturer. The sequence of the chapters reflects the product development lifecycle. Each chapter is focused on a specific University course and is divided into two sections: theory and implementation. The theory sections explain the main concepts and principles which remain valid across technological evolutions of medical instrumentation. The Implementation sections show how the theory is translated into a medical product. The Electrocardiograph (ECG or EKG) is used as an example as it is a suitable device to explore to fully understand medical instrumentation since it is sufficiently simple but encompasses all the main areas involved in developing medical electronic equipment. Key Features: Introduces a system-level approach to product design Covers topics such as bioinstrumentation, signal processing, information theory, electronics, software, firmware, telemedicine, e-Health and medical device certification Explains how to use theory to implement a market product (using ECG as an example) Examines the design and applications of main medical instruments Details the additional know-how required for product implementation: business context, system design, project management, intellectual property rights, product life cycle, etc. Includes an accompanying website with the design of the certified ECG product (www.gammacardiosoft.it/book) Discloses the details of a marketed ECG Product (from Gamma Cardio Soft) compliant with the ANSI standard AAMI EC 11 under open licenses (GNU GPL, Creative Common) This book is written for biomedical engineering courses (upper-level undergraduate and graduate students) and for engineers interested in medical instrumentation/device design with a comprehensive and interdisciplinary system perspective.
Download or read book Official Gazette written by Vietnam and published by . This book was released on 2019 with total page 964 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biomedical Materials written by Roger Narayan and published by Springer Nature. This book was released on 2020-12-09 with total page 728 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition provides a comprehensive discussion of contemporary materials used in biomedical research and development. The pedagogical writing style and structure provides students with an understanding of the fundamental concepts necessary to pursue research and industrial work in this growing area of biomedical science, including characteristics of biomaterials, biological processes, biocompatibility, and applications of materials in implants and medical instruments. Written by leading researchers in the field, this volume highlights important topics associated with biomedical engineering, medicine and surgery. The revised text contains updates that reflect recent technological advances in biomedical materials. It contains information on new characterization methods and applications for biomedical materials and incorporates suggestions that were offered by readers and educators using the first edition over the years. This textbook takes the reader to the forefront of biomedical materials development, providing graduate students with a taste of how the field is changing, while also serving as a useful reference to physicians and engineers.
Download or read book Quality Assurance written by Fred Owen and published by IChemE. This book was released on 1996 with total page 86 pages. Available in PDF, EPUB and Kindle. Book excerpt: This essential guide has now been fully revised and expanded to take into account the revision of ISO 9001 in 1994. The second edition also addresses the increasing demands, requirements and controls of information transfer, an activity which today is having a great impact on the success of engineering projects. The ISO 9000 series of standards is a formalized quality assurance management system designed to ensure that quality is built into every stage of the activity in hand. Wider application of the same principles across every aspect of a company's activities leads to Total Quality Management. The guidance given is intended to help contracting and operating companies in the chemical process industries, as well as those in the food, drink, pharmaceutical and building industries, as they strive for greater quality and to comply with ever-stricter legislation on safety and the environment.
Download or read book Culture Media Solutions and Systems in Human ART written by Patrick Quinn and published by Cambridge University Press. This book was released on 2014-03-27 with total page 307 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume describes culture media and solutions used in human ART; how they have been developed for in vitro human pre-implantation embryo development, the function and importance of the various components in media and solutions and how they interact, and how the systems in which these are used can influence outcomes. Chapters discuss inorganic solutes, energy substrates, amino acids, macromolecules, cytokines, growth factors, buffers, pH, osmolality, and the interaction of these parameters. The role of incubators and other physical factors are reviewed, along with the relevance and prospects of emerging technologies: morphokinetic analysis using time-lapse imaging and dynamic fluid incubation systems. Results of prospective randomized trials are emphasized to ascertain the added value of these techniques for selecting viable embryos. This comprehensive guide will be invaluable for embryologists, physicians and all personnel involved in the fluid products used in human ART seeking to optimize their successful use of these components.
Download or read book Device Inspections Guide written by and published by Washington Business Information. This book was released on 2003 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulatory Affairs for Biomaterials and Medical Devices written by Stephen F. Amato and published by Elsevier. This book was released on 2014-10-27 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance. Addresses global regulations and regulatory issues surrounding biomaterials and medical devices Especially useful for smaller companies who may not employ a full time vigilance professional Focuses on procedures and policies including risk management, intellectual protection, marketing authorisation, university patent licenses and general good practise manufacturing
Download or read book Emerging Trends in Medical Plastic Engineering and Manufacturing written by Markus Schönberger and published by William Andrew. This book was released on 2016-01-06 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: Emerging Trends in Medical Plastic Engineering and Manufacturing gives engineers and materials scientists working in the field detailed insights into upcoming technologies in medical polymers. While plastic manufacturing combines the possibility of mass production and wide design variability, there are still opportunities within the plastic engineering field which have not been fully adopted in the medical industry. In addition, there are numerous additional challenges related to the development of products for this industry, such as ensuring tolerance to disinfection, biocompatibility, selecting compliant additives for processing, and more. This book enables product designers, polymer processing engineers, and manufacturing engineers to take advantage of the numerous upcoming developments in medical plastics, such as autoregulated volume-correction to achieve zero defect production or the development of ‘intelligent’ single use plastic products, and methods for sterile manufacturing which reduce the need for subsequent sterilization processes. Finally, as medical devices get smaller, the book discusses the challenges posed by miniaturization for injection molders, how to respond to these challenges, and the rapidly advancing prototyping technologies. Provides a roadmap to the emerging technologies for polymers in the medical device industry, including coverage of ‘intelligent’ single use products, personalized medical devices, and the integration of manufacturing steps to improve workflows Helps engineers in the biomedical and medical devices industries to navigate and anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, and government regulations Presents tactics readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce defects in production and develop products that enable entirely new treatment possibilities
Download or read book European Communities Oil and Gas Technological Development Projects written by Commission of the European Communities and published by Springer Science & Business Media. This book was released on 1990-09-30 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction IX Community Energy Research and Development Strategy Programme Characteristics ImpLementation and Supervision Structure Status of Implementation Diffusion of Knowledge and Results Information for Future Proponents Breakdown of Support by Sector Breakdown of Projects by Sector Geophysics and Prospecting DrilLing 57 Production Systems 79 Secondary and Enhanced Recovery 183 Environmental Influence on Offshore 245 Auxiliary Ships and Submersibles 253 Pipelines 271 Transport 289 Natural Gas Technology 313 Energy Sources 323 Storage 333 MisceLlaneous 343 v PREFACE The 1973 oil crisis highLighted the dependency of the Community on imported hydrocarbons to satisfy its energy demand. Therefore, in order to improve security of suppLy the Community has deveLoped since 1973 a programme assisting the oiL industry to develop new technoLogies required for expLoiting oiL and gas resources outside and inside the Community territories. This programme (ReguLations 3056/73 and 3639/85) has aLLowed remarkabLe achievements in a sector where innovation is needed to take up the chaLLenge of producing oiL and gas in difficuLt environments. This report shows the achievements of the Community programme. It gives evidence of the high technicaL LeveL which has aLready been attained by the companies in the oiL and gas sector with the support of the Community.
Download or read book CENELEC 50128 and IEC 62279 Standards written by Jean-Louis Boulanger and published by John Wiley & Sons. This book was released on 2015-03-24 with total page 376 pages. Available in PDF, EPUB and Kindle. Book excerpt: CENELEC EN 50128 and IEC 62279 standards are applicable to the performance of software in the railway sector. The 2011 version of the 50128 standard firms up the techniques and methods to be implemented. This is a guide to its implementation, in order to understand the foundations of the standard and how it impacts on the activities to be undertaken, helping towards better a preparation for the independent evaluation phase, which is mandatory.
