Calmark’s product Neo-Bilirubin will obtain CE Mark approval in January 2020
Calmark’s product for the bilirubin biomarker will obtain its CE conformity marking after the turn of the year. A partial study of the verification and validation process still remains, and the study at Södersjukhuset is not finished.The majority of verification and validation testing, which is the final stage of the CE conformity marking process, has now been successfully performed. A couple of days of laboratory testing remain, however, and some of the planned children have not yet been included in the Södersjukhuset study. “We are very happy about the results so far. It is unfortunate