Design Dossier PDF Download

Author: Pamela Pease
Publisher:
ISBN: 9780977790500
Category : Art
Languages : en
Pages : 0

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Book Description
An introduction to design providing an overview to different aspects of design as well as the core fundamentals of the art.

Author: Ammar Grous
Publisher: John Wiley & Sons
ISBN: 1119137675
Category : Technology & Engineering
Languages : en
Pages : 510

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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: Peter J. Ogrodnik
Publisher: Academic Press
ISBN: 0128149639
Category : Technology & Engineering
Languages : en
Pages : 538

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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: Guy Julier
Publisher: Bloomsbury Publishing
ISBN: 1474289835
Category : Design
Languages : en
Pages : 248

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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

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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: Vietnam
Publisher:
ISBN:
Category : Gazettes
Languages : en
Pages : 964

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Book Description

Author: Smita Gopalaswamy
Publisher: CRC Press
ISBN: 1420064517
Category : Business & Economics
Languages : en
Pages : 260

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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: John J. Tobin
Publisher: John Wiley & Sons
ISBN: 3527644717
Category : Science
Languages : en
Pages : 304

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Book Description
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.

Author: Richard C. Fries
Publisher: CRC Press
ISBN: 1439894914
Category : Medical
Languages : en
Pages : 505

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Book Description
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.

Author: Roger Narayan
Publisher: Springer Nature
ISBN: 3030492060
Category : Technology & Engineering
Languages : en
Pages : 728

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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.