Welcome to kwrx quality regulatory excellence

kwrx quality regulatory excellence was conceived in March 2015 as a platform for sharing information, providing background and useful tweaks of the European Directives concerning Medical Devices, In-Vitro Diagnostic Devices and Active Implantable Devices. The site is intended for use by manufacturers, standardization bodies, regulatory bodies, and for conformity assessment purposes.

We publish articles about different topics in Medical Device Framework on a regular basis. The articles will guide you through the "jungle" of the European Medical Device Legislative and its requirements.


If you have any comments, questions or suggestions, please don't hesitate to contact us: Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein!.


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