In Vitro Diagnostic Devices
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Medical Devices And In Vitro Diagnostics
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Author : Christian Baumgartner
language : en
Publisher: Springer Nature
Release Date : 2023-08-26
Medical Devices And In Vitro Diagnostics written by Christian Baumgartner and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-26 with Technology & Engineering categories.
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
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Author : Chao-Min Cheng
language : en
Publisher: Springer
Release Date : 2015-07-16
In Vitro Diagnostic Devices written by Chao-Min Cheng and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-16 with Technology & Engineering categories.
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 Devices
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Author : Alfred Bracey
language : en
Publisher:
Release Date : 1987
In Vitro Diagnostic Devices written by Alfred Bracey and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1987 with Medical instruments and apparatus categories.
In Vitro Diagnostic Medical Devices Used For The Qualitative And Quantitative Detection Of Hepatitis C Rna
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-03-06
In Vitro Diagnostic Medical Devices Used For The Qualitative And Quantitative Detection Of Hepatitis C Rna written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-06 with Medical categories.
In Vitro Diagnostic Medical Devices Used For The Quantitative Detection Of Hiv 1 Nucleic Acid
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-03-06
In Vitro Diagnostic Medical Devices Used For The Quantitative Detection Of Hiv 1 Nucleic Acid written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-03-06 with Medical categories.
In Vitro Diagnostic Medical Devices Used For The Qualitative Detection Of Sars Cov 2 Nucleic Acid
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-10-02
In Vitro Diagnostic Medical Devices Used For The Qualitative Detection Of Sars Cov 2 Nucleic Acid written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-10-02 with Medical categories.
In Vitro Diagnostic Medical Devices Used For The Qualitative Detection Of Hiv 1 And Hiv 2 Nucleic Acid
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2021-11-30
In Vitro Diagnostic Medical Devices Used For The Qualitative Detection Of Hiv 1 And Hiv 2 Nucleic Acid written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-11-30 with Medical categories.
In Vitro Diagnostic Medical Devices For Monitoring Of Blood Glucose In Capillary Blood
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Author : World Health Organization
language : en
Publisher: World Health Organization
Release Date : 2023-11-23
In Vitro Diagnostic Medical Devices For Monitoring Of Blood Glucose In Capillary Blood written by World Health Organization and has been published by World Health Organization this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-23 with Medical categories.
Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03
Rare Diseases And Orphan Products written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-03 with Medical categories.
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.
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices
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Author : World Health Organization
language : en
Publisher:
Release Date : 2017-05-09
Who Global Model Regulatory Framework For Medical Devices Including In Vitro Diagnostic Medical Devices written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-05-09 with Law categories.
The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.