Want to speed up FDA approval or CE marking for your medical devices?
- Risk Manager
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.