Bente Lewinsky is a regulatory affairs specialist at Novo Nordisk, with 20 years’ experience focusing on quality systems and regulatory requirements for devices. She has experience in developing and re-engineering QA systems as well as worldwide product approvals and CE marking, and teaches internal and external courses on quality systems and regulatory requirements. She is also a member of the Eucomed Standards Task Force (since 2005) and of ISO/TC 210 WG1 on quality management systems for the medical device industry.