tracekey solutions GmbH

tracekey solutions GmbH is a German software company offering product traceability, serialization, and regulatory compliance solutions for the pharmaceutical and medical technology sectors. The company develops cloud-based software that helps manufacturers comply with requirements such as EU-FMD, MDR, EUDAMED, and other international track-and-trace regulations. Founded in 2013, tracekey has positioned itself particularly toward small and mid-sized healthcare manufacturers seeking SaaS-based compliance tools without large-scale enterprise implementation projects. Its offerings center on product identification, lifecycle traceability, regulatory data management, and cross-border compliance reporting for highly regulated industries.