Marion Lepmets

Bio

While in academia, I witnessed the struggles medical device companies face in complying with regulations and in bringing innovative products to market. I founded SoftComply in 2016 to automate and accelerate that process. Today we help over 1000 firms from start-ups to Fortune 100 companies in medical device and other safety critical domains to automate and integrate regulatory compliance in their software development lifecycle on Atlassian Jira and Confluence.

I have been involved in the development of software engineering standards in the International Standardization Organization (ISO/IEC JTC1 SC7) as a national delegate of Estonia, Luxembourg and Ireland. During that time I was involved in the work of IEC SC62A JWG3 working group that is responsible for the development and maintenance of the international standard for medical device software lifecycle processes (IEC 62304) as a co-author of IEC TR 80002-3, the process reference model for IEC 62304.

My specialties are medical device software development and risk management, IEC TR 80002-3, IEC 62304, ISO 14971, software process assessment, software process improvement, ISO/IEC 15504, ITIL, IT service quality.