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  7. UGA/FDA 11th Annual Medical Device Regulations Conference - 08/21/2024
  1. Office of Medical Device and Radiological Health Operations (OMDRHO)

Joint Regulatory | Virtual

Event Title
UGA/FDA 11th Annual Medical Device Regulations Conference
August 21, 2024


Date:
August 21, 2024
Organized By:


 UGA-FDA Medical Devices Conference Banner 2022

Location: All-Day Virtual Conference

Conference Registration | Virtual

August 21, 2024 (Conference)

* Co-sponsored by FDA and UGA.

 

The University of Georgia’s International Biomedical Regulatory Sciences Program (UGA) and US Food and Drug Administration (FDA) are co-sponsoring the 11th Annual UGA-FDA Medical Device Joint Regulatory Conference (UGA-FDA MDRC).

On August 21, 2024, the 11th Annual Medical Device Regulations Conference (MDRC) brings together key stakeholders in the medical device industry and the FDA to share insights, and advancement that would support small businesses. The growth of the medical device industry is driven by small businesses that play a pivotal role in revolutionizing healthcare through groundbreaking technologies and solutions. Medical device regulations are constantly evolving and it is a challenge for small businesses within the medical device industry to keep themselves current.  This year’s MDRC will be offered virtually as an opportunity to understand the complementary nature of information regarding current and forthcoming FDA policies, guidance, and regulations governing the medical device industry.

Conference Objectives

  • To share knowledge exchange around the concepts of regulatory compliance to advance product quality and efficacy by assuring benefit to the patient.
  • Enable participants to gain insights into emerging regulatory trends and requirements shaping the medical device industry.
  • Educate attendees on navigating regulatory compliance requirements essential for medical devices in the market.

UGA-FDA MDRC will offer insights into many of the challenges faced by industry and regulators
regarding the following topics:

  • Current medical device industry inspections and trends
  • Risk-based decisions for life-cycle management medical device products
  • Understanding the purpose of CAPA
  • Final rule that aligns with ISO13485 and ISO14971
  • Preparing management for quality system changes
  • Communicating effectively with FDA

View / download agenda.

Visit: https://www.fda.gov/about-fda/ora-program-areas/medical-device-radiological-health for additional information on ORA’s Medical Device & Radiological Health program area.

 
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