Health Information System - Medical Devices Nomenclature System

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F17%3A50014270" target="_blank" >RIV/62690094:18450/17:50014270 - isvavai.cz</a>
Alternative codes found
RIV/61989100:27240/17:10244470
Result on the web
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DOI - Digital Object Identifier
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Result language
angličtina
Original language name
Health Information System - Medical Devices Nomenclature System
Original language description
The subject of the article is to evaluate the current systems of internationally agreed generic descriptors for the identification of medical devices. The aim of this article is to assess the strengths and weaknesses of the Global Medical Device Nomenclature (GMDN), officially recognized within the European Economic Area (EEA), as compared to Unique Device Identity (UDI) valid in the United States. The methods used include a literature review of available professional sources, PEST analysis and guided structured interviews with experts from the Czech Association of Manufacturers of Medical Devices (CzechMed). Comparison of both systems was also performed. The introductory part of the article defines the basic concepts and obligations that international regulations set for MD manufacturers. It also describes the current situation in information systems associated with MDs. The comparison focuses on two transnational systems - Global Medical Devices Nomenclature (GMND) and Unique Device Identity (UDI). The synthesis of knowledge highlights the strengths and weaknesses of both systems. The conclusion of the article deals with the overall evaluation and recommendations on the given issue.
Czech name
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Czech description
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Project
<a href="/en/project/GA17-03037S" target="_blank" >GA17-03037S: Investment evaluation of medical device development</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Article name in the collection
CEFE 2017 – Central European Conference in Finance and Economic
ISBN
978-80-553-2906-2
ISSN
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e-ISSN
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Number of pages
10
Pages from-to
548-557
Publisher name
Technical University of Košice
Place of publication
Košice
Event location
Košice
Event date
May 20, 2017
Type of event by nationality
EUR - Evropská akce
UT code for WoS article
000503056700057

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