Full Schedule

8:00 AM – 9:00 AM East Coast USA Time

Breakfast

9:00 AM – 4:00 PM East Coast USA Time

The Device Design Change Life Cycle Experience

5:30 PM – 6:30 PM East Coast USA Time

Opening Reception

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

7:00 AM – 8:00 AM East Coast USA Time

Breakfast

8:00 AM – 8:10 AM East Coast USA Time

Opening Day 2

8:15 AM – 9:30 AM East Coast USA Time

Breaking Barriers: The Power of Regulatory Reliance

9:30 AM – 9:50 AM East Coast USA Time

BREAK

9:55 AM – 11:25 AM East Coast USA Time

Breakout #1: Risk Management - TBD

9:55 AM – 11:25 AM East Coast USA Time

Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update

9:55 AM – 11:25 AM East Coast USA Time

Breakout #3: Due Diligence – Are You Doing Enough? What About After Acquisition?

11:25 AM – 12:25 PM East Coast USA Time

LUNCH

12:30 PM – 2:00 PM East Coast USA Time

Breakout # 2: QMSR – Are You Ready?

12:30 PM – 2:00 PM East Coast USA Time

Breakout #1: Addressing 510(k) Review Challenges

12:30 PM – 2:00 PM East Coast USA Time

Breakout #3: Are You Processing and Investigating Complaints to the Right Level?

2:00 PM – 2:20 PM East Coast USA Time

BREAK

2:25 PM – 4:25 PM East Coast USA Time

FDA Mock Inspection

4:30 PM – 5:00 PM East Coast USA Time

Patient Experience Plenary, #2 Exploring Patient Experience

5:00 PM – 5:10 PM East Coast USA Time

Day 2 Close

5:30 PM – 7:00 PM East Coast USA Time

Networking Reception

7:00 AM – 8:00 PM East Coast USA Time

Breakfast

8:00 AM – 8:05 AM East Coast USA Time

Opening Day 3

8:10 AM – 9:10 AM East Coast USA Time

Global Shift in Clinical Expectations

9:10 AM – 9:30 AM East Coast USA Time

BREAK

9:35 AM – 11:35 AM East Coast USA Time

Investigator Insights

11:40 AM – 11:45 AM East Coast USA Time

Conference Close-Out