Since all milestones for 2018 have been achieved, at the start of 2019 Calmark's development project now enters a new phase that is usually called verification and validation.
In order to be able to CE mark the system, all tests must now be done on serially-produced products. Calmark has previously signed an agreement with Note AB for the manufacture of the reader. Now, Calmark has also signed an agreement with Frohe AB for manufacturing the single-use items. The production line will be developed in several steps to cope with rising volumes of the product.
Frohe specializes in the manufacture of complex and advanced plastic parts that require very high precision. The company holds ISO-13 485 certification, which is required to manufacture Calmark's products. Frohe also has extensive experience in manufacturing similar products for customers in the medical technology field.
“We are very pleased that the agreement between the companies is now finalized. It will be exciting to receive the first delivery of serially-produced single-use items that we so far are going to use for our continued internal tests, but which will later also be available in the hospitals for testing on newborn babies,” says Anna Söderlund, CEO at Calmark.