Design Dossier
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Applied Mechanical Design
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Author : Ammar Grous
language : en
Publisher: John Wiley & Sons
Release Date : 2018-05-15
Applied Mechanical Design written by Ammar Grous and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-15 with Technology & Engineering categories.
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.
Medical Device
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Author : Rommel Garcia
language : en
Publisher: Xlibris Corporation
Release Date : 2017-06-06
Medical Device written by Rommel Garcia and has been published by Xlibris Corporation this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06-06 with Medical categories.
This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who are in need. These experiences can and will be indispensable to beginners and professionals alike who are trying their hand in the medical device industry and to those who have not been out of their silo to help see how each of the systems relate to each as a whole. However, it should be noted that the contents of this book should be taken only as information and is not intended to demonstrate how companies can be in compliance. In some instances, there are multiple ways to go through the maze of regulations that are documented and made by agencies because the regulations are pretty much made and designed to be flexible and high level so that companies can adopt their systems, which are solely designed for their purposes. Therefore, this book will try to avoid complicated words and complex technical details of engineering and statistics. This book will strive to be an embodiment of the honest-to-goodness, everyday experiences and issues that folks experience while working in the medical device industry.
Revitalizing New Product Development From Clinical Trials Through Fda Review
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Author : United States. Congress. Senate. Committee on Labor and Human Resources
language : en
Publisher:
Release Date : 1996
Revitalizing New Product Development From Clinical Trials Through Fda Review written by United States. Congress. Senate. Committee on Labor and Human Resources and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996 with Law categories.
Design Of Biomedical Devices And Systems 4th Edition
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Author : Paul H. King
language : en
Publisher: CRC Press
Release Date : 2018-10-03
Design Of Biomedical Devices And Systems 4th Edition written by Paul H. King and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-10-03 with Medical categories.
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
Combination Products
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Author : Smita Gopalaswamy
language : en
Publisher: CRC Press
Release Date : 2008-04-22
Combination Products written by Smita Gopalaswamy and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-22 with Business & Economics categories.
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
Handbook Of Medical Device Design
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Author : Richard C. Fries
language : en
Publisher: CRC Press
Release Date : 2019-08-15
Handbook Of Medical Device Design written by Richard C. Fries and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-15 with Medical categories.
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.
Biomedical Product And Materials Evaluation
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Author : P.V. Mohanan
language : en
Publisher: Woodhead Publishing
Release Date : 2022-01-22
Biomedical Product And Materials Evaluation written by P.V. Mohanan and has been published by Woodhead Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-01-22 with Technology & Engineering categories.
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
Medical Product Regulatory Affairs
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Author : John J. Tobin
language : en
Publisher: John Wiley & Sons
Release Date : 2011-08-24
Medical Product Regulatory Affairs written by John J. Tobin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-24 with Science categories.
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.
Design Culture
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Author : Guy Julier
language : en
Publisher: Bloomsbury Publishing
Release Date : 2019-02-21
Design Culture written by Guy Julier and has been published by Bloomsbury Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-21 with Design categories.
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.
Medical Instrument Design And Development
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Author : Claudio Becchetti
language : en
Publisher: John Wiley & Sons
Release Date : 2013-07-29
Medical Instrument Design And Development written by Claudio Becchetti and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-07-29 with Science categories.
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.