Author: Christian Baumgartner
Publisher: Springer Nature
ISBN: 3031220919
Category : Technology & Engineering
Languages : en
Pages : 671
Book Description
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.
Medical Devices and In Vitro Diagnostics
Author: Christian Baumgartner
Publisher: Springer Nature
ISBN: 3031220919
Category : Technology & Engineering
Languages : en
Pages : 671
Book Description
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.
Publisher: Springer Nature
ISBN: 3031220919
Category : Technology & Engineering
Languages : en
Pages : 671
Book Description
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.
Medical Devices and in Vitro Diagnostics
Author: dr. Christian Baumgartner
Publisher:
ISBN: 9783030987435
Category :
Languages : en
Pages : 0
Book Description
Publisher:
ISBN: 9783030987435
Category :
Languages : en
Pages : 0
Book Description
Tools for Compliance for the Medical Device and in Vitro Diagnostic Product Industries
Author: United States. Bureau of Medical Devices and Diagnostic Products
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 24
Book Description
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 24
Book Description
Rare Diseases and Orphan Products
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
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.
Publisher: National Academies Press
ISBN: 0309158060
Category : Medical
Languages : en
Pages : 442
Book Description
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.
First WHO Model List of Essential In Vitro Diagnostics
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241210265
Category : Medical
Languages : en
Pages : 73
Book Description
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.
Publisher: World Health Organization
ISBN: 9241210265
Category : Medical
Languages : en
Pages : 73
Book Description
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.
In vitro diagnostic medical devices
Author: Medical Devices Agency. Adverse Incident Centre
Publisher:
ISBN:
Category :
Languages : en
Pages : 1
Book Description
Publisher:
ISBN:
Category :
Languages : en
Pages : 1
Book Description
Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
Author:
Publisher: World Health Organization
ISBN: 9240015310
Category : Business & Economics
Languages : en
Pages : 88
Book Description
Publisher: World Health Organization
ISBN: 9240015310
Category : Business & Economics
Languages : en
Pages : 88
Book Description
Public Health Effectiveness of the FDA 510(k) Clearance Process
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
Book Description
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.
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
Book Description
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.
General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580396823
Category :
Languages : en
Pages : 12
Book Description
Medical equipment, Diagnostic testing, Clinical investigation instruments, Diagnosis (medical), Personal health, Health and safety requirements
Publisher:
ISBN: 9780580396823
Category :
Languages : en
Pages : 12
Book Description
Medical equipment, Diagnostic testing, Clinical investigation instruments, Diagnosis (medical), Personal health, Health and safety requirements
In-Vitro Diagnostic Devices
Author: Chao-Min Cheng
Publisher: Springer
ISBN: 3319197371
Category : Technology & Engineering
Languages : en
Pages : 111
Book Description
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.
Publisher: Springer
ISBN: 3319197371
Category : Technology & Engineering
Languages : en
Pages : 111
Book Description
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.