9th Annual Medical Device Regulations Conference

Virtual & In-Person, University of Georgia Center for Continuing Education & Hotel, Athens, GA

November 15, 16, & 17, 2022

Medical Device Manufacturers and Innovators, Regulatory and Quality Assurance Professionals, Regulators and Academics are invited to attend the 9th 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.

Proposed Topics for the Conference (November 15 & 16):

  • CDRH/ORA Management Update
  • Medical Device Innovation: AI Machine Learning/Cybersecurity/Wearables
  • EU MDR/China Privacy/International Update
  • Compliance & Post-Marketing Update

Workshop (November 17)*

In today’s environment countless devices capture data on an ongoing basis. Surveillance cameras, smartphone tracking, temperature sensors, traffic sensors, and location identifiers are found in all types of devices. This trend is also true for medical devices.  A typical illustration is body worn continuous glucose meters, but other examples include pacemakers or kidney dialysis equipment. Medical devices with software and digital capability are increasing in popularity, and new challenges are introduced by these devices during the total product lifecycle (TPLC). This workshop will provide an overview of the design and maintenance of software-based devices from development to post-market surveillance using a glucose meter and insulin pump as a case study.* Workshop is solely sponsored by UGA.