Our Story

Throughout 10 years of working in several SaMD (Software as a Medical Device) companies, we deeply experienced the lack of understanding between the QARA team (Quality Assurance and Regulatory Affairs) and the Development team, which often resulted from one team blaming the other for having too much structure or requiring too much extra effort.

The main reason for this conflict was the lack of a tool on the market that could help provide both teams with what they needed. No solution effectively combined Agile methodology with ensuring regulation compliance.

This is why we have created TraceX: a 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!