In Vitro Diagnostic Devices

Author : Chao-Min Cheng
Publisher : Springer
ISBN 13 : 3319197371
Total Pages : 111 pages
Book Rating : 4.71/5 ( download)

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Download or read book In-Vitro Diagnostic Devices written by Chao-Min Cheng and published by Springer. This book was released on 2015-07-16 with total page 111 pages. Available in PDF, EPUB and Kindle. Book excerpt: Addressing the origin, current status, and future development of point-of-care diagnostics, and serving to integrate knowledge and tools from Analytical Chemistry, Bioengineering, Biomaterials, and Nanotechnology, this book focusses on addressing the collective and combined needs of industry and academia (including medical schools) to effectively conduct interdisciplinary research. In addition to summarizing and detailing developed diagnostic devices, this book will attempt to point out the possible future trends of development for point-of-care diagnostics using both scientifically based research and practical engineering needs with the aim to help novices comprehensively understand the development of point-of-care diagnostics. This includes demonstrating several common but critical principles and mechanisms used in point-of-care diagnostics that address practical needs (e.g., disease or healthcare monitoring) using two well-developed examples so far: 1) blood glucose meters (via electrochemistry); and, 2) pregnancy tests (via lateral flow assay). Readers of this book will come to fully comprehend how to develop point-of-care diagnostics devices, and will be inspired to contribute to a critical global cause – the development of inexpensive, effective, and portable in vitro diagnostics tools (for any purpose) that can be used either at home or in resource limited areas.

Author : Christian Baumgartner
Publisher : Springer Nature
ISBN 13 : 3031220919
Total Pages : 671 pages
Book Rating : 4.13/5 ( download)

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Download or read book Medical Devices and In Vitro Diagnostics written by Christian Baumgartner and published by Springer Nature. This book was released on 2023-08-26 with total page 671 pages. Available in PDF, EPUB and Kindle. Book excerpt: This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.

Author : United States. Bureau of Medical Devices and Diagnostic Products
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.73/5 ( download)

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Download or read book Tools for Compliance for the Medical Device and in Vitro Diagnostic Product Industries written by United States. Bureau of Medical Devices and Diagnostic Products and published by . This book was released on 1976 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Jeffrey Gibbs
Publisher :
ISBN 13 : 9781935065890
Total Pages : pages
Book Rating : 4.90/5 ( download)

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Download or read book Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment written by Jeffrey Gibbs and published by . This book was released on 2020-12-20 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Susan Onel
Publisher :
ISBN 13 : 9781402427749
Total Pages : 1112 pages
Book Rating : 4.43/5 ( download)

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Download or read book Medical Devices Law and Regulation Answer Book written by Susan Onel and published by . This book was released on 2016-11 with total page 1112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.

Author :
Publisher :
ISBN 13 :
Total Pages : 48 pages
Book Rating : 4.71/5 ( download)

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Download or read book Guideline for the Manufacture of in Vitro Diagnostic Products written by and published by . This book was released on 1990 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580822568
Total Pages : 16 pages
Book Rating : 4.67/5 ( download)

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Download or read book In Vitro Diagnostic Medical Devices. Evaluation of Stability of in Vitro Diagnostic Reagents written by British Standards Institute Staff and published by . This book was released on 1913-03-31 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: Diagnostic reagents, Diagnosis (medical), Chemical reagents, Stability testing, Stability, Storage, Life (durability), Verification, Medical equipment

Author : Alfred Bracey
Publisher :
ISBN 13 :
Total Pages : 78 pages
Book Rating : 4.82/5 ( download)

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Download or read book In Vitro Diagnostic Devices written by Alfred Bracey and published by . This book was released on 1987 with total page 78 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Peter J Ogrodnik
Publisher : Academic Press
ISBN 13 : 9780128001554
Total Pages : 0 pages
Book Rating : 4.50/5 ( download)

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Download or read book In Vitro Diagnostic devices written by Peter J Ogrodnik and published by Academic Press. This book was released on 2014-11-03 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Case Studies in Medical Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik’s Medical Device Design publication, and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. • These titles will assist anyone who is working in the medical devices industry or who is studying biomedical subject areas to design a successful medical device and avoid repeating past mistakes. • Written by an experienced medical device engineer and entrepreneur, with real world experience of developing and commercializing medical products. • Joins up theory and practice in an accessible style.

Author : Bernhard M. Maassen
Publisher : Springer Science & Business Media
ISBN 13 : 9401583196
Total Pages : 130 pages
Book Rating : 4.90/5 ( download)

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Download or read book In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States written by Bernhard M. Maassen and published by Springer Science & Business Media. This book was released on 2013-03-09 with total page 130 pages. Available in PDF, EPUB and Kindle. Book excerpt: Preface by T. Morrison, Director-General of the European Diagnostic Manufacturers Association. Contributors: W. Kewenig; G. Forlani, J. Marriage, G. Ulloa This book is based upon a report prepared at the request of the European Commission. Its purpose is to set out the existing laws regulating the development, production, distribution and use of in vitro diagnostic medical devices (IVDMD) in the U.K., Germany, France, Italy and Spain. Each national section has the same structure and covers the same ground in order to enable comparisons. IVDM Devices includes not only reagents, but also technical instruments, or combination of both, for human use. The book is directed towards industry and the regulation is covered with a high degree of specificity. This reference book, completely written in English, is the only comprehensive exposition of the laws of the five countries regarding IVDM Devices available. It is also the most convenient means of comparing those laws. As such, it will be a useful guide to all IVDM Devices manufacturers interested in the European market.