Calmark certified according to ISO 13485:2016
Calmark Sweden AB has carried out a certification of its quality management system in accordance with ISO 13485:2016. Review and certification were conducted by RISE Research Institutes of Sweden AB.Calmark Sweden AB has today received its certificate according to ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes). The certificate was awarded by RISE Research Institutes of Sweden AB (RISE AB), confirming that Calmark's quality management system meets the requirements for development, production, sales and distribution of in vitro diagnostic