Exciting news! We are proud to announce that OSAsense is CE certified, under the Medical Device Regulation (MDR) (class lla).

What is MDR? The MDR is an EU-wide regulation that standardises and improves safety and performance requirements for medical devices, such as our innovative OSAsense sleep apnoea exclusion diagnostics.

What does this certification mean for us? The Class IIa CE certification means OSAsense has undergone rigorous evaluation and meets the highest quality and safety standards. It allows us to confidently maintain our cutting-edge solution in the European market and enables us to make a significant impact in healthcare.

Big thanks to Evidencio, the incredible team behind this achievement! Evidencio has provided rapid MDR certification in a quick, easy and cost-effective process. The collaboration with Evidencio will ensure that OSAsense can quickly add new indications to its service palette in the same way in the near future. 

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