Want to speed up FDA approval or CE marking for your medical devices?


  • Risk Manager
  • eQMS

About us

We have extensive knowledge and expertise in software development
and regulatory affairs in the domain of medical devices.
Our team is located in Ireland and in Estonia.

The majority of our clients are from USA, UK, rest of Europe and they include start-ups as well as Fortune 500 companies.

  • Dr. Marion Lepmets
  • Co-Founder & CEO

Marion has an extensive academic background in medical device software development, she has been a member of international standards working groups & has co-authored IEC TR 80002-3.

  • Margus Nael
  • Co-Founder & VP of Engineering / CTO

Margus is an expert in Atlassian tools with outstanding industry experience in managing agile software teams in a number of companies, including Skype.

  • Matteo Gubellini
  • Co-Founder & VP of Regulatory Affairs / Chief Regulatory Officer

Matteo is an expert in Regulatory Affairs and Quality Management Systems in the medical device field with vast industry experience from several global medical device companies.