News & Media
Leipzig, 01/2010 - AJ Roboscreen became newly certified according to the DIN EN ISO 9001:2008 and DIN EN ISO 13485:2007 norms by mdc medical device certification GmbH, Stuttgart
We are proud to inform that we recently established a new IvD production unit at AJ Roboscreen and that we obtained the DIN EN ISO 9001:2008 and DIN EN ISO 13485:2007 certificates issued by the German notified body mdc Stuttgart. This brings us now in the position to manufacture CE labelled IvD kit which underly the highest safety level for targets listed in ANNEX II, List A and B of the IvD guideline 98/79/EC of the European Commission.
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