Quality & Regulatory Consultant,
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 Director of Operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. In this position she was responsible for overseeing all quality and regulatory functions, production, product procurement, and order fulfillment.
As a consultant at Qualitas Professional Services, LLC, Ms. Cordie now focuses on helping companies implement quality management systems, UDI solutions for labelling and FDA GUDID submissions, and providing validation, documentation and project management resources to global 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 terminology committee
- ISO (International Organization for Standardization) – serves as a US representative and participates in ISO/TC 198 (ISO 17664 & ISO 11139) and ISO/TC 210 (ISO 13485 & ISO 15223) working groups
- RAPS (Regulatory Affairs Professionals Society) – serving as chairperson of the RAPS Twin Cities Chapter and a member of the RAPS EU Committee
- AHRMM Learning UDI Community