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Plenary

QMSR Implementation Update

Thursday, April 23, 2026
8:10 AM - 8:45 AM East Coast USA Time
Location: Regency Ballroom - 3rd Floor

    Moderator(s)

  • Susan Matthias

    Consumer Safety Officer, Special Assistant, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
    FDA

    View Slides

    • Speaker(s)

  • Karen Masley-Joseph

    Senior Advisor, Office of Medical Device and Radiological Health Inspectorate (OMDRHI), Medical Products Inspectorate (MPI), Office of Inspections and Investigations (OII)
    FDA

  • Keisha Thomas

    Associate Director for Compliance & Quality, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
    FDA

Is your QMSR implementation complete and ready for FDA interaction? You are required to be in compliance with the QMSR as of February 2, 2026! FDA will provide updates on QMSR implementation expectations and field experiences thus far. Don’t miss the follow-on session to discuss the parts of the Compliance Program (CP) for Inspection of Medical Device Manufacturers that have been updated to reflect the new QMSR regulations. the move of compliance functions to CDRH and the merge of the PMA Pre/Post Approval into one CP Inspection of Medical Device Manufacturers CP into this one.