CE conformity marking and the development of medical devices follows a seven-step process, where the first three steps involve requirements capture and development. The product is then verified against the prescribed requirements and validated by would-be users (steps four and five). The development project is then closed, moving to production in step six. In the final and seventh step, the product formally obtains its CE marking.
The CE certification of Calmark’s tests for children requires the product to be validated with blood from new-born infants in step five. In these cases, Calmark has to work with hospital research entities to finalize validation. The LDH test for COVID-19 will be used for adult patients, which means that Calmark can conduct both verification and validation on its own account in accordance with the directives applied by the Company.
“We can today announce that the COVID-19 product complies with our technical requirements. The analytical results fall within the expected range when compared to the reference laboratory at Karolinska University Hospital,” says Anna Söderlund, CEO of Calmark. “We feel comfortable moving to the final phase of the project. This is the result of a development effort carried out at unprecedented speed, and I would like to thank my remarkable team for their good work!”