We’re thrilled to announce that COSMAS, our new digital platform for Tissue, Stem Cell & Gene Therapies is CE-marked and registered for the EU market!
COSMAS is now a CE-marked In Vitro Diagnostic medical device and can be sold in the European Union as of November 1st. Our COSMAS team and Quality & regulatory team planned the CE mark documentation submission throughout the summer and was prepared and delivered to our European Authorized Representative on October 27th.
On 1st November, the European Authorized Representative informed us that the verification had been completed and that COSMAS had been registered with their competent authority for medical devices. The CE mark is a huge achievement as it supports the first implementation of the COSMAS in the world.