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Global Medical Device Nomenclature ( GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Unique Device Identification. The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section ...
A medical classification is used to transform descriptions of medical diagnoses or procedures into standardized statistical code in a process known as clinical coding. Diagnosis classifications list diagnosis codes, which are used to track diseases and other health conditions, inclusive of chronic diseases such as diabetes mellitus and heart ...
Nomenclature ( UK: / noʊˈmɛŋklətʃər, nə -/, US: / ˈnoʊmənkleɪtʃər /) [1] [2] is a system of names or terms, or the rules for forming these terms in a particular field of arts or sciences. [3] The principles of naming vary from the relatively informal conventions of everyday speech to the internationally agreed principles, rules ...
Common nomenclature systems are taken directly from the ECRI Institute Universal Medical Device Nomenclature System. Manufacturer: This is the name of the company that received approval from the FDA to sell the device, also known as the Original Equipment Manufacturer (OEM).
Biomedical engineering ( BME) or medical engineering is the application of engineering principles and design concepts to medicine and biology for healthcare applications (e.g., diagnostic or therapeutic purposes). BME is also traditionally logical sciences to advance health care treatment, including diagnosis, monitoring, and therapy.
The Medical Device Directive — Council Directive 93/42/EEC of 14 June 1993 concerning medical devices —is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market ...
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