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 will later be released on the market. In preparation, Note AB has now delivered the first reader produced in their production premises.
“We have taken a big step today as the first reader from Note is ready. We are ahead of schedule and can now start the important verification and validation phase according to the new plan we have developed. The first reader should be used in the lab but will later be out in the hospitals for testing on newborn babies,” says Anna Söderlund, CEO at Calmark.