Medical Devices And In Vitro Diagnostics

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Medical Devices and In Vitro Diagnostics

Christian Baumgartner,Johann Harer,Jörg Schröttner
Medical Devices and In Vitro Diagnostics Book PDF

Author : Christian Baumgartner,Johann Harer,Jörg Schröttner
Publisher : Springer Nature
Page : 671 pages
File Size : 52,9 Mb
Release : 2023-08-26
Category : Technology & Engineering
ISBN : 9783031220913

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Medical Devices and In Vitro Diagnostics by Christian Baumgartner,Johann Harer,Jörg Schröttner Pdf

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.

First WHO Model List of Essential In Vitro Diagnostics

World Health Organization
First WHO Model List of Essential In Vitro Diagnostics Book PDF

Author : World Health Organization
Publisher : World Health Organization
Page : 73 pages
File Size : 53,5 Mb
Release : 2019-05-16
Category : Medical
ISBN : 9789241210263

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First WHO Model List of Essential In Vitro Diagnostics by World Health Organization Pdf

The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.

General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing

British Standards Institute Staff
General Requirements for in Vitro Diagnostic Medical Devices for Self Testing Book PDF

Author : British Standards Institute Staff
Publisher : Unknown
Page : 12 pages
File Size : 43,7 Mb
Release : 2002-05-08
Category : Electronic
ISBN : 0580396827

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General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing by British Standards Institute Staff Pdf

Medical equipment, Diagnostic testing, Clinical investigation instruments, Diagnosis (medical), Personal health, Health and safety requirements

In-Vitro Diagnostic Devices

Chao-Min Cheng,Chen-Meng Kuan,Chien-Fu Chen
In Vitro Diagnostic Devices Book PDF

Author : Chao-Min Cheng,Chen-Meng Kuan,Chien-Fu Chen
Publisher : Springer
Page : 106 pages
File Size : 46,9 Mb
Release : 2015-07-16
Category : Technology & Engineering
ISBN : 9783319197371

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In-Vitro Diagnostic Devices by Chao-Min Cheng,Chen-Meng Kuan,Chien-Fu Chen Pdf

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.

Performance Evaluation of in Vitro Diagnostic Medical Devices

British Standards Institute Staff
Performance Evaluation of in Vitro Diagnostic Medical Devices Book PDF

Author : British Standards Institute Staff
Publisher : Unknown
Page : 18 pages
File Size : 44,9 Mb
Release : 2002-05-07
Category : Electronic
ISBN : 0580396509

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Performance Evaluation of in Vitro Diagnostic Medical Devices by British Standards Institute Staff Pdf

Medical equipment, Performance testing, Clinical investigation instruments, Diagnosis (medical), Patients, Diagnostic testing

Tools for Compliance for the Medical Device and in Vitro Diagnostic Product Industries

United States. Bureau of Medical Devices and Diagnostic Products
Tools for Compliance for the Medical Device and in Vitro Diagnostic Product Industries Book PDF

Author : United States. Bureau of Medical Devices and Diagnostic Products
Publisher : Unknown
Page : 24 pages
File Size : 50,9 Mb
Release : 1976
Category : Medical instruments and apparatus
ISBN : UCR:31210023586173

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Tools for Compliance for the Medical Device and in Vitro Diagnostic Product Industries by United States. Bureau of Medical Devices and Diagnostic Products Pdf

In Vitro Diagnostic Medical Devices. Evaluation of Stability of in Vitro Diagnostic Reagents

British Standards Institute Staff
In Vitro Diagnostic Medical Devices Evaluation of Stability of in Vitro Diagnostic Reagents Book PDF

Author : British Standards Institute Staff
Publisher : Unknown
Page : 16 pages
File Size : 45,5 Mb
Release : 1913-03-31
Category : Electronic
ISBN : 0580822567

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In Vitro Diagnostic Medical Devices. Evaluation of Stability of in Vitro Diagnostic Reagents by British Standards Institute Staff Pdf

Diagnostic reagents, Diagnosis (medical), Chemical reagents, Stability testing, Stability, Storage, Life (durability), Verification, Medical equipment

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

World Health Organization
WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices Book PDF

Author : World Health Organization
Publisher : Unknown
Page : 72 pages
File Size : 55,5 Mb
Release : 2017-05-09
Category : Law
ISBN : 9241512350

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WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices by World Health Organization Pdf

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.

Medical Devices and in Vitro Diagnostics

dr. Christian Baumgartner,Johann Harer,Jörg Schröttner
Medical Devices and in Vitro Diagnostics Book PDF

Author : dr. Christian Baumgartner,Johann Harer,Jörg Schröttner
Publisher : Unknown
Page : 0 pages
File Size : 43,6 Mb
Release : 2023
Category : Electronic
ISBN : 3030987434

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Medical Devices and in Vitro Diagnostics by dr. Christian Baumgartner,Johann Harer,Jörg Schröttner Pdf

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

Bernhard M. Maassen,R. Whaite
In vitro Diagnostic Medical Devices Law and Practice in Five EU Member States Book PDF

Author : Bernhard M. Maassen,R. Whaite
Publisher : Springer Science & Business Media
Page : 130 pages
File Size : 55,5 Mb
Release : 2013-03-09
Category : Law
ISBN : 9789401583190

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In vitro Diagnostic Medical Devices: Law and Practice in Five EU Member States by Bernhard M. Maassen,R. Whaite Pdf

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 Industry in China

Haibo Song,Lizhong Dai
In Vitro Diagnostic Industry in China Book PDF

Author : Haibo Song,Lizhong Dai
Publisher : Springer Nature
Page : 580 pages
File Size : 49,8 Mb
Release : 2024-01-09
Category : Medical
ISBN : 9789819931101

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In Vitro Diagnostic Industry in China by Haibo Song,Lizhong Dai Pdf

This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of twelve parts, including the overview on the IVD industry in China in 2021, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, point-of-care testing, molecular diagnosis, blood and body fluid diagnosis, microbial detection, laboratory assembly line, etc. In this second edition, the new contents added include the development of new coronavirus molecular diagnostic products, flight mass spectrometry, tandem mass spectrometry, tumor markers, ELISA immune reagents, autoimmune diagnostics, concomitant diagnosis, fecal and intestinal microecology detection, pathological diagnosis, raw materials for in vitro diagnostic reagents, standard substances and quality controls for in vitro diagnostic reagents, etc., making the content of the whole book more novel and rich. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

Public Health Effectiveness of the FDA 510(k) Clearance Process

Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Public Health Effectiveness of the FDA 510 k Clearance Process Book PDF

Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process
Publisher : National Academies Press
Page : 141 pages
File Size : 53,7 Mb
Release : 2010-10-04
Category : Medical
ISBN : 9780309162906

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Public Health Effectiveness of the FDA 510(k) Clearance Process by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process Pdf

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.