Instructor Profile
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.
About Us
EIT Digital invests in strategic areas to accelerate the market uptake and scaling of research-based digital technologies (deep tech) focusing on Europe’s key societal challenges: Digital Tech, Digital Cities, Digital Industry, Digital Wellbeing, and Digital Finance.
E-Learning
EIT Digital provides online and blended Innovation and Entrepreneurship education to raise quality, increase diversity and availability of the top-level content provided by our partner network of leading technical universities around Europe.
EU Collaborations
EIT Digital is at the centre of digital in Europe and works with other EU organisations, such as the European Innovation Council, the European Central Bank and the European Investment Fund.
ICARUS AI
ICARUS AI is a fully customizable AI enabled e-learning platform.