April 26, 2024
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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