Welcome to the Pacific Design & Manufacturing Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.
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 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 also involved in Regulatory Affairs Professionals Society (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.