Full Schedule

7:30 AM - 8:30 AM East Coast USA Time

Breakfast

Location: Franklin CD - 2nd Floor

7:30 AM - 4:00 PM East Coast USA Time

Registration

Location: Franklin Foyer - 2nd Floor

8:30 AM - 4:00 PM East Coast USA Time

What is Your Post-Market Surveillance Data Really Telling You: Methods and Tips to Effectively Apply Risk-Based Principles When Evaluating Post-Market Surveillance Data

Location: Franklin AB - 2nd Floor

Moderator: – FDA Rescue

Speaker: – STERIS Corporation

Speaker: – FDA Rescue

Speaker: – Eli Lilly and Company

Workshop

5:00 PM - 6:00 PM East Coast USA Time

Opening Reception

Location: Delaware - 2nd Floor

Networking Event

7:00 AM - 8:00 AM East Coast USA Time

Breakfast

Location: Regency Ballroom Foyer - 3rd Floor

7:00 AM - 5:00 PM East Coast USA Time

Registration

Location: Regency Ballroom Foyer - 3rd Floor

8:00 AM - 8:30 AM East Coast USA Time

Let's Make a Difference

Location: Regency Ballroom - 3rd Floor

Plenary

9:00 AM - 9:45 AM East Coast USA Time

Solutions exchange: What Works (and what doesn’t) When Working With AI in QA/RA

Location: Regency Ballroom - 3rd Floor

Moderator: – Qserve Group

Moderator: – Eli Lilly and Company

Plenary

9:45 AM - 10:05 AM East Coast USA Time

BREAK

Location: Regency Ballroom - 3rd Floor

10:05 AM - 10:40 AM East Coast USA Time

FDA OII and Office of Medical Device & Radiological Health

Location: Regency Ballroom - 3rd Floor

Moderator: – FDA

Speaker: – FDA

Plenary

10:40 AM - 11:40 AM East Coast USA Time

Medical Device User Fee Amendments (MDUFA) Update

Location: Regency Ballroom - 3rd Floor

Moderator: – STERIS Corporation

Moderator: – MDMA & ELIQUENT Life Sciences

Speaker: – Medical Device Manufacturers Association (MDMA)

Speaker: – FDA (Virtual)

Plenary

11:40 AM - 12:40 PM East Coast USA Time

LUNCH

Location: Delaware A-C - 2nd Floor

12:40 PM - 2:40 PM East Coast USA Time

Breakout #1: Overcoming Challenges in Medical Device Design and Development

Location: Franklin AB - 2nd Floor

Moderator: – STERIS Corporation

Moderator: – Boston Scientific

Moderator: – Eli Lilly and Company

Moderator: – FDA Rescue

Speaker: – Philips Healthcare

Speaker: – FDA Rescue

Speaker: – STERIS Corporation

Breakout

12:40 PM - 1:40 PM East Coast USA Time

Breakout #2: De-Mystifying Verification and Validation of Manufacturing Processes

Location: Franklin CD - 2nd Floor

Moderator: – FDA

Speaker: – FDA

Breakout

1:40 PM - 2:40 PM East Coast USA Time

Breakout #2: Identifying & Handling Product Software Defects / Bugs / Anomalies

Location: Franklin CD - 2nd Floor

Moderator: – Abbott

Speaker: – FDA

Speaker: – Abbott

Breakout

2:40 PM - 3:25 PM East Coast USA Time

Breakout #1: Embracing AI to Build a Better Operation and QMS

Location: Franklin AB - 2nd Floor

Moderator: – Brooke & Associates

Speaker: – ERA Sciences

Speaker: – Luova Solutions

Breakout

2:40 PM - 3:25 PM East Coast USA Time

Breakout #2: Managing Data Integrity Across the Total Product Lifecycle

Location: Franklin CD - 2nd Floor

Moderator: – QualityHub, Inc.

Speaker: – The Eriah Group / FluoGuide / Sedana Medical / BioPorto

Speaker: – FDA

Breakout

3:25 PM - 3:45 PM East Coast USA Time

BREAK and move back to plenary

Location: Regency Ballroom Foyer - 3rd Floor

3:45 PM - 4:45 PM East Coast USA Time

Managing Material Shortages in a Global Regulatory Landscape

Location: Regency Ballroom - 3rd Floor

Moderator: – Pathway for Patient Health

Moderator: – Boston Scientific

Speaker: – Qserve Group

Speaker: – FDA (Virtual)

Speaker: – Edwards Lifesciences

Plenary

4:45 PM - 4:50 PM East Coast USA Time

Close Out

Location: Regency Ballroom - 3rd Floor

Plenary

6:00 PM - 8:00 PM East Coast USA Time

MedCon Annual Dinner - Franklin Park Conservatory and Botanical Gardens

Networking Event

8:30 AM - 9:00 AM East Coast USA Time

Patient Experience Plenary #2

Moderator: – Edwards Lifesciences

Speaker: – Parent/Patient

4:35 PM - 5:05 PM East Coast USA Time

Patient Experience Plenary #2

Moderator: – Edwards Lifesciences

Moderator: – Children's Heart Foundation

7:00 AM - 8:00 AM East Coast USA Time

Breakfast

Location: Regency Ballroom Foyer - 3rd Floor

7:00 AM - 5:00 PM East Coast USA Time

Registration

Location: Regency Ballroom Foyer - 3rd Floor

8:00 AM - 8:10 AM East Coast USA Time

Day 2 Open

Location: Regency Ballroom - 3rd Floor

Plenary

8:10 AM - 8:45 AM East Coast USA Time

QMSR Implementation Update

Location: Regency Ballroom - 3rd Floor

Moderator: – FDA

Speaker: – FDA

Plenary

8:45 AM - 10:10 AM East Coast USA Time

Updated Compliance Program (CP) for Inspection of Medical Device Manufacturers

Location: Regency Ballroom - 3rd Floor

Moderator: – FDA

Speaker: – FDA

Plenary

10:10 AM - 10:30 AM East Coast USA Time

BREAK

Location: Regency Ballroom Foyer - 3rd Floor

10:30 AM - 12:30 PM East Coast USA Time

Breakout #1: The Mechanics of an FDA Inspection

Location: Franklin AB - 2nd Floor

Moderator: – FDA

Speaker: – STERIS Corporation

Speaker: – Brooke & Associates

Speaker: – FDA

Breakout

10:30 AM - 11:30 AM East Coast USA Time

Breakout #2: EU MDR – State of Play and Targeted Revisions

Location: Franklin CD - 2nd Floor

Moderator: – Qserve Group

Moderator: – Medical Device, IVD and Combo Product Expert

Speaker: – AKRA Team

Speaker: – Arnold & Porter

Speaker: – TUV SUD

Speaker: – Axon Lawyers

Breakout

11:30 AM - 12:30 PM East Coast USA Time

Breakout #2: Horizontal Legislation in EU, A Complex Growing Web of Supporting Legislation

Location: Franklin CD - 2nd Floor

Moderator: – Qserve Group

Moderator: – Medical Device, IVD and Combo Product Expert

Speaker: – AKRA Team

Speaker: – Arnold & Porter

Speaker: – TUV SUD

Speaker: – Axon Lawyers

Breakout

12:30 PM - 1:30 PM East Coast USA Time

LUNCH

Location: Delaware A-C - 2nd Floor

1:30 PM - 3:00 PM East Coast USA Time

Breakout #1: CDRH Premarket Update

Location: Franklin AB - 2nd Floor

Moderator: – MDMA & ELIQUENT Life Sciences

Moderator: – STERIS Corporation

Speaker: – STERIS Corporation

Speaker: – FDA

Speaker: – Eliquent Life Sciences

Breakout

1:30 PM - 3:00 PM East Coast USA Time

Breakout #2: Quality Beyond the Factory's Walls: Managing Supplier Risk and Quality From Off-the-Shelf to Custom Contract Manufactured Products

Location: Franklin CD - 2nd Floor

Moderator: – FDA

Moderator: – Eli Lilly and Company

Moderator: – FDA

Speaker: – West Pharmaceutical Services

Speaker: – Roche Diagnostics

Speaker: – FDA

Breakout

3:00 PM - 3:20 PM East Coast USA Time

BREAK

Location: Regency Ballroom Foyer - 3rd Floor

3:20 PM - 4:35 PM East Coast USA Time

Global Regulatory Collaboration/Reliance Strategies, Alignment Challenges & “Relianomics” for Medical Devices

Location: Regency Ballroom - 3rd Floor

Moderator: – Medical Device, IVD and Combo Product Expert

Speaker: – D.K. Kim International Center for Regulatory Sciences at USC Officer

Speaker: – Boston Scientific (Virtual)

Speaker: – GE Healthcare

Plenary

5:05 PM - 5:15 PM East Coast USA Time

Day 2 Close

Location: Regency Ballroom - 3rd Floor

Plenary

5:15 PM - 6:30 PM East Coast USA Time

Networking Reception

Location: Regency Ballroom Foyer - 3rd Floor

Networking Event

7:00 AM - 8:00 AM East Coast USA Time

Breakfast

Location: Regency Ballroom Foyer - 3rd Floor

7:00 AM - 11:00 AM East Coast USA Time

Registration

Location: Regency Ballroom Foyer - 3rd Floor

8:00 AM - 8:05 AM East Coast USA Time

Opening Day 3

Location: Regency Ballroom - 3rd Floor

Plenary

8:05 AM - 9:05 AM East Coast USA Time

How You Can Influence and Support Leadership and a Quality Culture in your Organization

Location: Regency Ballroom - 3rd Floor

Moderator: – Medical Device, IVD and Combo Product Expert

Speaker: – Arnold Porter

Speaker: – Fresenius Medical Care

Speaker: – Johnson & Johnson

Speaker: – AbbVie, Inc.

Plenary

9:05 AM - 9:40 AM East Coast USA Time

Update from CDRH's New Center Director

Location: Regency Ballroom - 3rd Floor

Moderator: – FDA

Speaker: – FDA (Virtual)

Plenary

9:40 AM - 10:00 AM East Coast USA Time

BREAK

Location: Regency Ballroom Foyer - 3rd Floor

10:00 AM - 12:00 PM East Coast USA Time

Investigator Insights

Location: Regency Ballroom - 3rd Floor

Moderator: – Abbott

Speaker: – FDA

Plenary

12:00 PM - 12:05 PM East Coast USA Time

Conference Close-out

Location: Regency Ballroom - 3rd Floor