Great satisfaction for the 1st MDR Certificate obtained by 3DIEMME with Thema support
With great pride and satisfaction, we communicate that our Customer 3DIEMME srl has obtained its first MDR (EU) 2017/745 certificate from the IMQ Notified Body for the RealGUIDE™️ 5.0 software, with the support of Thema experts.
As part of Thema, we have developed the strategy, prepared the documents, collaborated with the IMQ Notified Body and assisted the Customer during the MDR inspection, in full synergy and overcoming every difficulty.
Thanks to the commitment of everyone, an advanced diagnostic imaging and prosthetic modelling Software for dental and maxillo-facial field can finally be spread throughout Europe, in full compliance with the regulations.
Learn more about 3DIEMME and RealGUIDE™️ 5.0 software.
Learn more about Thema CE certification support services
Do you want to market your device in Europe?
All Medical Devices must have the CE marking in order to be marketed in Europe.
If your product is a non-class I device, it is necessary to intervene and a CE certificate must be issued by a Notified Body (NB).
By relying on Thema you will receive the support of experts and professionals which is what you need to achieve your goals.
Starting from an in-depth analysis and a strategic-regulatory plan, we provide complete support in obtaining the CE certification for Medical Devices and in Vitro Diagnostic Medical Devices, in accordance to the regulations.
Contact us for further information.