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 & regulatory affairs of medical devices.
Our team is located in Ireland and in Estonia.

  • 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.