Understanding the basics of EU and US regulations is crucial to avoid unnecessary delays and costs in the development of new medical devices. This session will help entrepreneurs and start-ups navigate the key regulatory frameworks, highlight the importance of clearly defining the device, target users, and business model, and provide guidance on how to build an optimal strategy that brings innovations to patients faster.

About the speaker

Mats Högberg, Director of MedTech/IVD at RegSmart Life Science AB, is a senior executive with extensive global experience in the medical technology and life sciences sectors. With a career spanning over 30 years, Mats has worked for several international corporations and co-founded two life sciences companies.

About Regsmart

RegSmart is a life science regulatory consultancy that helps companies navigate the complex regulatory landscape of pharmaceuticals, medical devices, and diagnostics. With deep scientific knowledge and extensive experience from regulatory authorities and industry, they provide strategic and practical support from early research through to market access and beyond