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Full Schedule

  • Wednesday, April 23, 2025
  • 7:00 AM – 8:00 AM East Coast USA Time
    Breakfast
  • 8:00 AM – 8:20 AM East Coast USA Time
    Let's Make a Difference!
  • 8:25 AM – 8:55 AM East Coast USA Time
    Patient Experience Plenary #1
  • 9:00 AM – 9:30 AM East Coast USA Time
    The Solution Exchange – Culture of Quality
  • 9:30 AM – 9:45 AM East Coast USA Time
    BREAK
  • 9:50 AM – 10:25 AM East Coast USA Time
    CDRH Overview
  • 10:30 AM – 11:05 AM East Coast USA Time
    FDA OMDRHI Overview (Office of Medical Device & Radiological Health Inspectorate
  • 11:10 AM – 11:40 AM East Coast USA Time
    FDA Reorganization: The New Responsibilities of OMDRHI (Office of Medical Device and Radiological Health Inspectorate) and CDRH
  • 11:45 AM – 12:15 PM East Coast USA Time
    Fostering Medical Device Improvement: FDA’s Voluntary Improvement Program
  • 12:15 PM – 1:15 PM East Coast USA Time
    LUNCH
  • 1:20 PM – 2:35 PM East Coast USA Time
    Breakout #1: International: Experience and Challenges With MDR/IVDR and EUDAMED
  • 1:20 PM – 2:35 PM East Coast USA Time
    Breakout #2: Implementation of Artificial Intelligence in Manufacturing and the Quality System
  • 1:20 PM – 2:35 PM East Coast USA Time
    Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From FDA and Industry Experts
  • 2:35 PM – 2:50 PM East Coast USA Time
    BREAK
  • 2:55 PM – 3:55 PM East Coast USA Time
    Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
  • 2:55 PM – 3:55 PM East Coast USA Time
    Breakout #2: Supply Chain Resiliency: Evolving Challenges and Best Practices
  • 2:55 PM – 3:55 PM East Coast USA Time
    Breakout #3: Are You Correctly Accessing Quality System Activities When Quality System Functions Are Spread Out Across Different Locations?
  • 3:55 PM – 4:15 PM East Coast USA Time
    BREAK and move back to plenary
  • 4:20 PM – 5:05 PM East Coast USA Time
    FDA’s QMSR Implementation Status
  • 5:10 PM – 5:15 PM East Coast USA Time
    Close-Out
  • 6:00 PM – 8:00 PM East Coast USA Time
    MedCon Annual Dinner