After working with various medical device software companies, Dr. Marion Lepmets decided to create regulatory compliance software apps that would fast-track regulatory compliance for companies entering the medical device domain so they could place their innovative products to market faster. Previously, Marion worked as a Senior Research Fellow at the Regulated Software Research Centre in Dundalk Institute of Technology, on the development and commercialization of medical device software development process framework (MDevSPICE). Her postdoctoral research was funded by the National Research Fund of Luxembourg and she conducted it at the Public Research Centre Henri Tudor. She graduated from Tampere University of Technology (Finland) with Dr. of Technology (Software Engineering) in 2007. She has been involved in the development of software engineering standards in the International Standardization Organization (ISO/IEC JTC1 SC7) for the last 10 years as a national delegate of Estonia, Luxembourg and most recently of Ireland. For the last three years, she has also been 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). She is also the co-author of IEC TR 80002-3, the process reference model for IEC 62304, which was published in June 2014. She holds a MSc degree in IT from TalTech and a PhD in Software Engineering from Tampere University of Technology.