Factsheet for Manufacturers of Medical Devices PDF Download
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Author:
Publisher:
ISBN: 9789279897023
Category :
Languages : en
Pages :
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Book Description
This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In Vitro Medical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in vitro diagnostic medical devices. References to Annexes and Articles in this factsheet refer to the MDR (2017/745/EU).
Author:
Publisher:
ISBN: 9789279897023
Category :
Languages : en
Pages :
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Book Description
This Factsheet is aimed at manufacturers of medical devices. For a general overview of the impact of the In Vitro Medical Devices Regulation (IVDR) on manufacturers see the Factsheet for manufacturers of in vitro diagnostic medical devices. References to Annexes and Articles in this factsheet refer to the MDR (2017/745/EU).
Author:
Publisher:
ISBN: 9789279897078
Category :
Languages : en
Pages :
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Book Description
The new Medical Devices Regulation (2017/745/ EU) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, that improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market. Transitional periods are planned to smooth the application of the new Regulations. However, you should bear in mind that consultants, in-house professionals, and Notified Bodies will all get busier as the deadline draws closer.
Author: Christian Baumgartner
Publisher: Springer Nature
ISBN: 3031220919
Category : Technology & Engineering
Languages : en
Pages : 671
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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.
Author:
Publisher:
ISBN: 9789279904318
Category :
Languages : en
Pages :
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Book Description
The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, which improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations are directly applicable and do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market.
Author:
Publisher:
ISBN: 9789279904097
Category :
Languages : en
Pages :
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Book Description
The new Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) bring EU legislation into line with technical advances, changes in medical science, and progress in law making. The new Regulations create a robust, transparent, and sustainable regulatory framework, recognised internationally, which improves clinical safety and creates fair market access for manufacturers. In contrast to Directives, Regulations are directly applicable and do not need to be transposed into national law. The MDR and the IVDR will therefore reduce the risks of discrepancies in interpretation across the EU market.
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580773273
Category :
Languages : en
Pages : 62
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Book Description
Diagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Clinical investigation instruments, Diagnostic reagents, Clinical laboratory equipment, Reagent solutions, Definitions, Measurement
Author:
Publisher:
ISBN:
Category : Diagnosis, Laboratory
Languages : en
Pages : 48
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Book Description
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141
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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.
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580769429
Category :
Languages : en
Pages : 22
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Book Description
Diagnosis (medical), Medical equipment, Product information, Instructions for use, Labels, Labelling (process), Clinical investigation instruments, Clinical laboratory equipment, Health service personnel
Author: United States. Bureau of Medical Devices and Diagnostic Products
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 24
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Book Description
