Back To Schedule
Wednesday, June 22 • 4:15pm - 5:15pm
#376: How to Manage Device Design Changes Under EU MDR

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-644-L04-P ; CME 1.00; RN 1.00

This session will discuss the most common challenges with managing design changes under EU MDR. Join us to understand how to communicate what constitutes a significant change and create a strategy for design change compliance under MDR.

Learning Objectives

Describe what constitutes a significant change; Create a strategy for design change compliance under MDR.


Demetra Macheras, MBA


Common Challenges with Managing Design Changes Under EU MDR
Catherine E Kang, PhD, MS

EU Medical Device Regulations
James Lorkowski

avatar for James Lorkowski

James Lorkowski

Director, Device and Drug Device Combination CMC Regulatory, Merck & Co., Inc., United States
James Lorkowski is currently in charge of Novel and Innovative Technologies in the Device and Drug Device Combination Products CMC regulatory group within Merck. He has over a decade of experience in the medical device industry facilitating clearances and approvals of new and complex... Read More →

Catherine Kang

Project Engineer, RQM+ , United States
Catherine has a BSc and an MSc in Bioengineering, and a PhD in Chemical Engineering and Applied Chemistry. She has worked with pharmaceuticals, medical devices, and combination products for 10+ years. She has experience in leading cross-functional teams, authoring and editing US... Read More →
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, Inc., United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S. and Canada regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and final regulatory... Read More →

Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 183 C McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  10: RegCMC-Product Quality, Session