8th Annual Medical Device Regulations Conference/Workshop*

Medical Device manufacturers and Innovators, Regulatory and Quality Assurance Professionals, Regulators and Academics are invited to attend the 8th Annual 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):
View Day 1 & 2 Conference Agenda on UGA Medical Device Regulations Conference website.

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

Proposed Topic for the MDR/IVDR Workshop* (Sept. 23, 2021):
View Day 3 Workshop Agenda on UGA Medical Device Regulations Conference website.

• 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

Event Date:

Location:

Costs:
Please Note: Early bird registration is $100 off and the deadline is September 7, 2021.

Conference Virtual

• On or Before 9/7/21: $499
• After 9/7/21: $599

Workshop Virtual

• On or Before 9/7/21: $199
• After 9/7/21: $299

Conference Workshop Combo Virtual

• On or Before 9/7/21: $699
• After 9/7/21: $799

Students

• Conference Virtual: $25
• Workshop Virtual: $25

Government and Academia

• Conference Virtual: $50
• Workshop Virtual: $50

Register 3 – 4th one free! Any organization who registers 3 participants is eligible for 1 free registration!
Contact Alex Ligon for more information at alex.ligon@georgiacenter.uga.edu.

Event Cancellation Policies:
(1) A cancellation received by 5:00 p.m. ET on or before September 13, 2021 will be refunded, minus a $35 processing fee. No refunds will be issued thereafter. (2) To change or cancel your registration, call (706) 542-3537, Monday through Friday, 8:00 a.m. to 5:00 p.m. ET.

Program Contact Information:
Program Contact:
Contact Us – UGA Medical Device Regulations Conference website

Registration Contact:
The Georgia Center
(706) 542-3537
questions@georgiacenter.uga.edu

Special Needs:
If you require special services, contact Sales@georgiacenter.uga.edu by September 13, 2021.