mediaire certified as medical product manufacturer as per DIN EN ISO 13485:2016 & software mdbrain CE-marked.
mediaire GmbH was certified as medical product manufacturer as per DIN EN ISO 13485:2016 by the appointed authority Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH. Additionally mediaire’s new Neuroradiology-Software mdbrain received the CE-mark as per 93/42/EWG annex IV . mediaire is now officially recognized as medical product manufacturer.
To comply with the high standards of the Medical Device Directive a ISO 13485 quality management system was established.