MedCon 2024, co-sponsored by the FDA

Back to MedCon Agenda 2024

April 26, 2024

@

10:40 am

-

11:40 am

What You Need to Know About FDA’s Transition to Incorporate ISO 13485 by Reference Into 21 CFR 820 (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

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

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