Lena Cordie has over 20 years of quality and project management experience including: • 10 years in project management at Target Financial Services; • 11 years as Direct of Operations at Key Surgical; • 4+ years as President, Consultant at Qualitas Professional Services. As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on training and helping companies implement quality management systems, UDI solutions for labelling and GUDID submissions, and providing internal audit, validation, documentation and project management resources to medical device companies. She is an active member of: • AAMI (Association for the Advancement of Medical Instrumentation) – serves as a voting member of many sterilization standards committees and co-chairs the AAMI ST/WG 5 - Terminology committee • ISO (International Organization for Standardization) – serves as a US expert on the following committees: o ISO/TC 198 WG 5 – Terminology o ISO/TC 198 WG 11 - General criteria for sterilization processes and sterilizing equipment o ISO/TC 198 WG 12 – Information for reprocessing of resterilizable devices o ISO/TC 210 WG 1 – Application of quality systems to medical devices o ISO/TC 210 WG 2 – General aspects stemming from the application of quality principles to medical devices o ISO/TC 210 WG 3 – Symbols and nomenclature for medical devices • RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter and as a member of the RAPS European Council (REC) • Member of ASQ (American Society for Quality)