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 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 Applied Mechanical Design written by Ammar Grous and published by John Wiley & Sons. This book was released on 2018-02-15 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 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 Reliable Design of Medical Devices written by Richard C. Fries and published by CRC Press. This book was released on 2005-11-21 with total page 490 pages. Available in PDF, EPUB and Kindle. Book 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.
Download or read book Design of Biomedical Devices and Systems written by Dragan Primorac and published by CRC Press. This book was released on 2014-07-29 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.
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 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 Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2011-08-24 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
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 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 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 Biomedical Product and Materials Evaluation written by P.V. Mohanan and published by Woodhead Publishing. This book was released on 2022-01-22 with total page 808 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies Discusses standardization and ethical hurdles in biomedical product development and how to overcome them
Download or read book Object Oriented Methodologies and Systems written by Elisa Bertino and published by Springer Science & Business Media. This book was released on 1994-09-07 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume presents the proceedings of the International Symposium on Object-Oriented Methodologies and Systems (ISOOMS '94), held in Palermo, Italy in September 1994 in conjunction with the AICA 1994 Italian Computer Conference. The 25 full papers included cover not only technical areas of object-orientation, such as databases, programming languages, and methodological aspects, but also application areas. The book is organized in chapters on object-oriented databases, object-oriented analysis, behavior modeling, object-oriented programming languages, object-oriented information systems, and object-oriented systems development.
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: Detailed discussion of the history, current status and significance of ART media and the culture systems for their use.
Download or read book Pharmaceutical and Medical Device Safety written by Sonia Macleod and published by Bloomsbury Publishing. This book was released on 2019-02-21 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control.
