Breakout #2: Are You Processing and Investigating Complaints to the Right Level?

Thursday, April 24, 2025

12:30 PM – 2:00 PM East Coast USA Time

Location: Delaware CD – 2nd Floor

Participate in a session to work through a case study that touches on all aspects of the complaint handling process, including returned product analysis and MDR reportability.

Moderator(s)

Kim Trautman

Expert
Medical Device, IVD and Combo Product Expert

Speaker(s)

Monica Wilkins

VP Regulatory, Quality & Compliance
Abbott, Illinois, United States

View Slides
Aaron Dunbar

Vice President of Quality Systems & Post Market
Boston Scientific
Phil Pontikos

Retired, FDA