MedCon 2025 has been announced!

April 23 - 25, 2025

Columbus, OH

AFDO RAPS Healthcare Products Collaborative
Presents
MedCon Conference

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2024 MedCon Agenda

April 26, 2024 @ 10:40 am

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11:40 am

What You Need to Know About FDA’s Transition to the Quality Management System Regulation (QMSR)

Plenary Session

Hear from FDA CDRH and the Office of Medical Devices and Radiological Health (OMDRHO) to learn plans and key updates on timing and implementation steps of the QMSR. Session participants will gain understanding of the status of the FDA’s rule and implementation activities from FDA experts.

Moderators

Sean Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA

Susan Matthias, Consumer Safety Officer Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Speakers

Karen Masley-Joseph, Senior Advisor, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

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

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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