Caroline Byrd

Director Commercial RA/QA
Leica Biosystems Richmond, Inc.

Caroline Byrd is the Director of Commercial RA/QA for Leica Biosystems. Before joining Leica in May 2019, Caroline initiated and led the program to implement the EU MDR across Abbott’s Medical Device division. She has been exploring the practical implementation of the MDR since Q4 2016, in particular the impact of clinical evidence requirements on PMCF investments, data organization to deliver efficient post market reporting processes, and UDI data needs.

Caroline has held other roles as Director of Clinical Evaluation and Director of R&D Engineering & Scientific Services for Abbott (as St. Jude Medical), and various Quality and Operations roles in her almost 20 year career in medical devices. Caroline holds a B.S. in Mechanical Engineering from Washington University in St. Louis.

Presentation(s):

• Transitioning from MDD to MDR: Case Studies, Tips, and Lessons Learned from Large-Scale Implementations of the EU MDR

  Tuesday, September 24
  4:00 PM – 5:30 PM