Lily Alexander is the Quality Systems Manager at UHN in Toronto. She is currently implementing an ISO 13485 Medical Device Quality Management System across UHN for the design and development of medical devices. Lily started her career in healthcare working as a RT in various downtown hospitals in Toronto then moved to Medical Device development in 1991. She has been involved in the field of Quality at companies such as Baxter Healthcare, Cedara Software and Regulatory Compliance Associates. Lily is experienced as an Internal Quality and Lead Auditor for ISO 9001:2000/ISO 13485:2003 and has experience working with GMP 21CFR Part 820 and the Canadian Medical Device Regulations.