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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
European Committee on Antimicrobial Susceptibility Testing (EUCAST) is a scientific committee for defining guidelines to interpret antimicrobial resistance. [1] It was formed in 1997 and is jointly organized by ESCMID , ECDC and other European laboratories.
The European Pharmacopoeia: setting quality standards for Europe and beyond and supplying pharmaceutical reference standards [ edit ] Published and regularly updated by the EDQM/ Council of Europe in English and French, the two official languages of the Council of Europe, the Ph. Eur. is a compendium of official quality standards for medicines ...
CHKS Ltd is a specialist provider of healthcare accreditation programmes based in the UK and accredited to ISQua and ISO 17021:2011 standards [49] United States [ edit ]
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 the ...
EN 62353:2014 Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment; Moreover, there are a lot of ISO and IEC standards that were accepted as "European Standard" (headlined as EN ISO xxxxx) and are valid in the European Economic Region.
The E.U. and its European Medicines Agency began accepting eCTD submissions in 2003. [10] In February 2015, the "EMA announced it would no longer accept paper application forms for products applying to the centralized procedure beginning 1 July 2015."
The logo of the European Committee for Standardization for aluminium recycling. The European Committee for Standardization (CEN, French: Comité Européen de Normalisation) is a public standards organization whose mission is to foster the economy of the European Single Market and the wider European continent in global trading, the welfare of European citizens and the environment by providing ...