Full Schedule

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

Breakfast

7:30am - 4:00pm East Coast USA Time

Registration

8:30am - 4:00pm East Coast USA Time

Case Studies in Medical Device Post Market Activites

5:00pm - 6:30pm East Coast USA Time

Opening Reception

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

01 - Breakfast

7:00am - 5:00pm East Coast USA Time

02 - Registration

8:00am - 8:30pm East Coast USA Time

03 - Let's Make a Difference

8:30am - 9:00pm East Coast USA Time

04 - Patient Experience Plenary #1

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

05 - Solutions Exchange: What Works (and doesn’t) When Working With AI

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

06 - BREAK

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

07 - Update from CDRH’s New Center Director, Michelle Tarver

10:40am - 11:15am East Coast USA Time

08 - FDA OII and Office of Medical Device & Radiological Health

11:15am - 12:15pm East Coast USA Time

09 - Medical Device User Fee Amendments ( MDUFA) Update

12:15pm - 1:15pm East Coast USA Time

010 - LUNCH

1:15pm - 3:15pm East Coast USA Time

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

1:15pm - 2:15pm East Coast USA Time

012 - Breakout #2: Validation of Manufacturing Process/Systems - Equipment Qualification

2:15pm - 3:15pm East Coast USA Time

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

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

015 - Breakout #2: Data Integrity (e.g. how to set up systems - )

4:00pm - 4:20pm East Coast USA Time

016 - BREAK and move back to plenary

4:20pm - 5:20pm East Coast USA Time

017 - Managing Material Shortages in a Global Regulatory Landscape

5:20pm - 5:25pm East Coast USA Time

018 - Close Out

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

019 - MedCon Annual Dinner - Franklin Park Conservatory and Botanical Gardens

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

020 - Breakfast

7:00am - 5:00pm East Coast USA Time

021 - Registration

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

022 - Day 2 Open

8:10am - 10:10am East Coast USA Time

023 - QMSR Implementation Update

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

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

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

025 - BREAK

10:30am - 12:30pm East Coast USA Time

026 - Breakout #1: The Mechanics of an FDA Inspection: A View from Many Perspectives

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

027 - Breakout #2: Horizontal legislation in EU, a complex growing web of supporting legislation

11:30am - 12:30pm East Coast USA Time

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

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

029 - LUNCH

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

030 - Breakout #1: CDRH Premarket Update

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

031 - Breakout # 2: Bringing New Products to Life Compliantly: Challenges in Design Development

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

032 - BREAK

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

033 - Regulators: Global Harmonization and Convergence Initiatives

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

034 - Patient Experience Plenary #2

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

0.35 - Day 2 Close

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

036 - Networking Reception

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

Breakfast

7:00am - 11:30am East Coast USA Time

Registration

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

Opening Day 3

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

Leadership and Quality Culture (Presentation and Panel)

9:05am - 9:25am East Coast USA Time

BREAK

9:25am - 11:25am East Coast USA Time

Investigator Insights

11:25am - 11:30am East Coast USA Time

Conference Close-out