In preparation of the CE marking of its first product bilirubin, Calmark will now enter the verification and validation phase, in which the product will be tested to ensure that it meets all technical requirements and all applicable standards. During this phase, it is important that validation and verification are done on products equivalent to those that later will be released on the market. In preparation, Frohe AB has delivered the first single-use items produced in their production premises.
“A big step has been taken today with the delivery of the first single-use products from Frohe. We are ahead of schedule and can now start the important verification and validation process earlier than planned. The first single-use items will now be used in the lab but will later be available in the hospitals for testing on newborn babies,” says Anna Söderlund, CEO of Calmark.