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Author: Peter J. Ogrodnik Publisher: Academic Press ISBN: 0128149639 Category : Technology & Engineering Languages : en Pages : 538
Book Description
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: Peter J. Ogrodnik Publisher: Academic Press ISBN: 0128149639 Category : Technology & Engineering Languages : en Pages : 538
Book Description
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: Ammar Grous Publisher: John Wiley & Sons ISBN: 1119137683 Category : Technology & Engineering Languages : en Pages : 504
Book Description
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.
Author: Guy Julier Publisher: Bloomsbury Publishing ISBN: 1474289835 Category : Design Languages : en Pages : 248
Book Description
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.
Author: Richard C. Fries Publisher: CRC Press ISBN: 1000696952 Category : Medical Languages : en Pages : 491
Book Description
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.
Author: Smita Gopalaswamy Publisher: CRC Press ISBN: 1420064517 Category : Business & Economics Languages : en Pages : 260
Book Description
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
Author: Dragan Primorac Publisher: CRC Press ISBN: 146656914X Category : Medical Languages : en Pages : 494
Book Description
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.
Author: Society for News Design Publisher: Rockport Publishers ISBN: 1564969789 Category : Magazine design Languages : en Pages : 112
Book Description
"The Best of Newspaper Design 24th Edition, the latest in Rockport's highly respected series, presents the winning entries from the Society for News Design's annual competition for 2002. Selected by a panel of judges from over 14,000 international publication entries, this inspirational volume sets the bar for excellence in journalistic design. Bold, full-color layouts feature the best-of-the-best in news, features, portfolios visuals, and more, and each entry is accompanied by insightful commentary on the elements that made the piece a standout winner. A beautiful resource for anyone involved in journalistic design, this is the book in which every industry professional aspires to one day see their work.
Author: Roger Narayan Publisher: Springer Nature ISBN: 3030492060 Category : Technology & Engineering Languages : en Pages : 728
Book Description
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.
Author: Peter J. Ogrodnik
Author: Peter J. Ogrodnik
Author: Pamela Pease
Author: Ammar Grous
Author: Guy Julier
Author: Vietnam
Author: Richard C. Fries
Author: Smita Gopalaswamy
Author: Dragan Primorac
Author: Society for News Design
Author: Roger Narayan