Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Service, where she works with medical device and IVD companies to implement ISO 13485 and FDA QS Regulation compliant quality management systems, supporting processes to comply with FDA and international regulatory requirements related to quality systems, risk management, and global regulatory compliance related to labelling and Unique Device Identification (UDI) requirements. She is a member of AAMI Sterilization Standards, ISO/TC 198 and ISO/TC 210 work groups. She is an active member of RAPS, and is chairperson for the Twin Cities Chapter, a member of the RAPS European Committee (REC) and a leader of the UK Local Networking Group.