Our Story

During more than 10 years experience working in several SaMD companies (Software as a Medical Device), we deeply experienced the lack of understanding between the QARA team (Quality Assurance and Regulatory Affairs) and the Development team. One team usually blaming another for putting too much structure / rules and requesting extra effort.

The main reason for it is that no tool on the market could help them to provide at the same time what both teams needed: There were no solution combining the Agile methodology and ensuring compliance with regulation.

This is why we have created TraceX: The solution that combines modern and easy to use eQMS with an integrated Project Management tool like Jira.

With TraceX, we have created the solution we would have loved to find on the market at the time!