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Wednesday, April 22, 2026
7:00am - 8:00am
East Coast USA Time
01 - Breakfast
7:00am - 8:00am
East Coast USA Time
Breakfast
7:00am - 5:00pm
East Coast USA Time
02 - Registration
7:00am - 5:00pm
East Coast USA Time
Registration
8:00am - 8:30pm
East Coast USA Time
03 - Let's Make a Difference
8:00am - 8:30am
East Coast USA Time
Let's Make a Difference
Plenary
8:30am - 9:00pm
East Coast USA Time
04 - Patient Experience Plenary #1
8:30am - 9:00am
East Coast USA Time
Patient Experience Plenary #1
Plenary
9:00am - 9:45am
East Coast USA Time
05 - Solutions Exchange: What Works (and doesn’t) When Working With AI
9:00am - 9:45am
East Coast USA Time
Solutions Exchange: What Works (and doesn’t) When Working With AI
Moderator:
Gert Bos
– Qserve Group
Moderator:
John Krug
– Eli Lilly and Company
Plenary
9:45am - 10:05am
East Coast USA Time
06 - BREAK
9:45am - 10:05am
East Coast USA Time
BREAK
10:05am - 10:40am
East Coast USA Time
07 - Update from CDRH’s New Center Director, Michelle Tarver
10:05am - 10:40am
East Coast USA Time
Update from CDRH’s New Center Director, Michelle Tarver
Speaker:
Gina Brackett
– FDA (Invited)
Plenary
10:40am - 11:15am
East Coast USA Time
08 - FDA OII and Office of Medical Device & Radiological Health
10:40am - 11:15am
East Coast USA Time
FDA OII and Office of Medical Device & Radiological Health
Moderator:
Susan Matthias
– FDA (Invited)
Plenary
11:15am - 12:15pm
East Coast USA Time
09 - Medical Device User Fee Amendments ( MDUFA) Update
11:15am - 12:15pm
East Coast USA Time
Medical Device User Fee Amendments ( MDUFA) Update
Moderator:
Bill Brodbeck
– STERIS Corporation
Plenary
12:15pm - 1:15pm
East Coast USA Time
010 - LUNCH
12:15pm - 1:15pm
East Coast USA Time
LUNCH
1:15pm - 3:15pm
East Coast USA Time
011 - Breakout #1: Overcoming Challenges in Medical Device Design and Development
1:15pm - 3:15pm
East Coast USA Time
Breakout #1: Overcoming Challenges in Medical Device Design and Development
Moderator:
Bill Brodbeck
– STERIS Corporation
Moderator:
Aaron Dunbar
– Boston Scientific
Moderator:
John Krug
– Eli Lilly and Company
Breakout
1:15pm - 2:15pm
East Coast USA Time
012 - Breakout #2: Validation of Manufacturing Process/Systems - Equipment Qualification
1:15pm - 2:15pm
East Coast USA Time
Breakout #2: De-Mystifying Verification and Validation of Manufacturing Processes
Moderator:
Susan Matthias
– FDA (Invited)
Breakout
2:15pm - 3:15pm
East Coast USA Time
013 - Breakout #2: Identifying & Handling Product Software Defects / Bugs / Anomalies
2:15pm - 3:15pm
East Coast USA Time
Breakout #2: Identifying & Handling Product Software Defects / Bugs / Anomalies
Breakout
3:15pm - 4:00pm
East Coast USA Time
014 - Breakout #1: Embracing AI to Build a Better Operation and QMS
3:15pm - 4:00pm
East Coast USA Time
Breakout #1: Embracing AI to Build a Better Operation and QMS
Speaker:
Eric Henry
– Brooke & Associates
Breakout
3:15pm - 4:00pm
East Coast USA Time
015 - Breakout #2: Data Integrity (e.g. how to set up systems - )
3:15pm - 4:00pm
East Coast USA Time
Breakout #2: Managing Data Integrity Across the Total Product Lifecycle
Moderator:
Sean Boyd
– QualityHub, Inc.
Breakout
4:00pm - 4:20pm
East Coast USA Time
016 - BREAK and move back to plenary
4:00pm - 4:20pm
East Coast USA Time
BREAK and move back to plenary
4:20pm - 5:20pm
East Coast USA Time
017 - Managing Material Shortages in a Global Regulatory Landscape
4:20pm - 5:20pm
East Coast USA Time
Managing Material Shortages in a Global Regulatory Landscape
Speaker:
Aaron Dunbar
– Boston Scientific
Plenary
5:20pm - 5:25pm
East Coast USA Time
018 - Close Out
5:20pm - 5:25pm
East Coast USA Time
Close Out
Plenary
6:00pm - 8:00pm
East Coast USA Time
019 - MedCon Annual Dinner - Franklin Park Conservatory and Botanical Gardens
6:00pm - 8:00pm
East Coast USA Time
MedCon Annual Dinner - Franklin Park Conservatory and Botanical Gardens
Networking Event