On December 15, we were very happy to receive the announcement from our Notified Body that we have fulfilled all the requirements of EU MDR IIa. The whole team is so proud to have achieved this ambitious step!
This milestone also points to the next one. We have already defined our global sales strategy and reinforced it with several delegation trips organized by the foreign chambers of commerce. 
We also completed our application for FDA approval in the USA and expect to receive a response in the first quarter of 2024. For the upcoming distribution in countries such as Canada and Australia, we will fulfill the requirements of the MDSAP. This entitles us to distribute in 44 countries. 

If you are interested in our global sales strategy, feel free to contact me