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

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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 →

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