Lena Cordie
Owner/Principal Consultant, Qualitas Professional Services, LLC
Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 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 labeling 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; and RAPS (Regulatory Affairs Professionals Society) - serving as chairperson of the RAPS Twin Cities Chapter.

Upcoming Webinar
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Recorded Webinar
Medical Device Software Verification and Validation
Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood.
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How to Prepare for the Transition to the new EU Medical Device Regulation (MDR)
The new EU regulations are much tougher than the directives they are replacing, and they will transform the way you do business in the EU. In May 2017, the European Union (EU) published two new regulations, one for medical devices (MDR) and another for in vitro diagnostic medical devices (IVDR). These regulations are the first major changes in the EU’s medical device regulatory environment in more than 20 years and will replace the three existing Medical Device Directives. There are many changes that anyone designing, manufacturing, and/or marketing medical devices into the EU needs to be aware of when compared to the original Medical Device Directives.
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ISO 9001:2015 Quality Management System: Preparing for a Successful Transition
In this webinar our speaker Lena Cordie will train on how to carry out a gap analysis against the requirements of ISO 9001:2015 to make the transition smooth and transparent. This exercise will provide your organization with structured assistance to highlight the extent to which existing systems and controls cover the requirements of ISO 9001:2015, or to identify an implementation action plan, where needed.
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Update on Global UDI Initiatives and Post-Submission Responsibilities
This webinar will provide updates on the progress of Unique Device Identification regulations around the world, including the status of the FDA's implementation, requirements for UDI in the new EU MDR, and the development of initiatives in other countries including Australia, Canada, Japan and Asia.
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