Qualitas Professional Services, LLC
Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Services, where she works with medical device, dental and IVD companies to implement ISO 13485 and FDA QS Regulation compliant quality management systems; incorporate processes to comply with FDA, EU and other international regulatory requirements related to quality systems, risk management; and 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 a member of ASQ, and as a member of Regulatory Affairs Professionals Society (RAPS), serves as the chairperson for the Twin Cities Chapter, is a member of the RAPS European Committee (REC), and a leader of the UK Local Networking Group.
Monday, September 14, 2020
12:00 PM – 1:30 PM EDT