Calmark’s test Neo-LDH enters verification and validation phase to obtain CE mark

Calmark’s test Neo-LDH enters verification and validation phase to obtain CE mark

Nyheter
News
Calmark Sweden AB (publ) announces today that the development project for the Company's product for newborns, Neo-LDH, is now progressing to verification and validation. This phase, which is one of the final elements of the process, is estimated to last for approximately two months. When it is completed, regulatory documentation will be compiled in order to achieve the CE Mark approval.

"Today's decision marks an important milestone for Calmark. Our preliminary results show that we meet our technical requirements for the product. We are confident to bring the project into the final phases, starting the verification and validation processes." says Anna Söderlund, CEO of Calmark. "We hope to be able to CE mark the product before the regulations are changed on 26 May."

Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.