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Breakout

Breakout #3: Are You Processing and Investigating Complaints to the Right Level?

Thursday, April 24, 2025
12:30 PM – 2:00 PM East Coast USA Time
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)

  • Gina Brackett

    Assistant Director, Establishment Assessment Team 1, Office of Regulatory Programs, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
    FDA (Invited)

    • Speaker(s)

  • Monica Wilkins

    VP Regulatory and Quality
    Abbott

  • Aaron Dunbar

    Vice President of Quality Systems & Post Market
    Boston Scientific

  • Phil Pontikos

    Investigator, Medical Device National Expert, Office of Inspections and Investigations (OII), Office of Medical Device and Radiological Health Inspectorate (OMDRHI)
    FDA