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8th Annual Medical Device Regulations Conference

September 21-23, 2021

Medical Device Manufacturers and Innovators, Regulatory and Quality Assurance Professionals, Regulators and Academics are invited to attend the 8th Annual UGA/FDA Medical Device Regulations Conference!

This conference is co-sponsored by the US Food and Drug Administration and the University of Georgia’s International Biomedical Regulatory Sciences program. It will provide educational and networking opportunities to help shape and advance the future of medical device regulatory sciences. Using a tutorial approach, experienced leaders from the FDA, Notified Bodies, the medical device industry, and consulting firms will present and engage the audience on issues related to medical device regulations.

The 8th Annual UGA Medical Device Regulations Conference will be held virtually by the University of Georgia, College of Pharmacy on September 21-23, 2021. The conference will be of special interest to professionals working in the medical device industry in the US to hear the current thinking on a broad range of topics outlined under the Agenda.  The conference will be opened by leadership at FDA and UGA and the topics will be presented by highly experienced professionals and technical experts from FDA and medical device industry.

Proposed Topics for the Conference (Sept. 21-22, 2021):

  • FDA Updates: CDRH and ORA
  • Notified Bodies Updates
  • International Updates
  • COVID-19 EUA Lessons Learned
  • Remote Regulatory Assessment
  • Tissue-based Devices
  • Digital Devices

VIEW CONFERENCE AGENDA

 Proposed Topic for the MDR/IVDR Workshop* (Sept. 23, 2021):

  • Economic operators role
  • PRRC expectations and implementation
  • From ER to GSPR
  • QMS changes for MDR / IVDR
  • Brexit – SwissXit
  • Hands-on Technical Documentation preparation

* Workshop is solely sponsored by UGA.

VIEW WORKSHOP AGENDA