Medical Devices and In Vitro Diagnostics

Medical Devices and In Vitro Diagnostics PDF

Author: Christian Baumgartner

Publisher: Springer Nature

Published: 2023-08-26

Total Pages: 671

ISBN-13: 3031220919

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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.

In-Vitro Diagnostic Devices

In-Vitro Diagnostic Devices PDF

Author: Chao-Min Cheng

Publisher: Springer

Published: 2015-07-16

Total Pages: 111

ISBN-13: 3319197371

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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.

In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States

In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States PDF

Author: Bernhard M. Maassen

Publisher: Springer Science & Business Media

Published: 2013-03-09

Total Pages: 130

ISBN-13: 9401583196

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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.

In Vitro Diagnostic devices

In Vitro Diagnostic devices PDF

Author: Peter J Ogrodnik

Publisher: Academic Press

Published: 2014-11-03

Total Pages: 0

ISBN-13: 9780128001554

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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.

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-04-03

Total Pages: 442

ISBN-13: 0309158060

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Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

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