SGS Lake Nona MedTech Regulatory Innovation Symposium

Description

Lake Nona MedTech & Regulatory Innovation Symposium

Thursday, October 29, 2026

8:00 AM – 7:30 PM

GuideWell Innovation Center
6555 Sanger Rd, Orlando, FL 32827

Networking Reception & Plug and Play Health Innovation Lounge: 6:00–7:30 PM

Chamber Member Exclusive: Save $75 on registration! DM us for your promo code.

Objectives & Agenda

Registration & Networking Breakfast - 7:30am - 8:00am

• 8:00 - 8:15 - Welcome & Opening Remarks - SGS | Lake Nona Chamber | RAPS Florida
• 8:15 - 8:45 - Lake Nona Innovation Ecosystem - Plug and Play + Lake Nona Chamber
• 8:45 - 8:50 - Speaker Transition
• 8:50 - 9:25 - Innovation, Translational Research & Entrepreneurship in Medical City - Dr. Kiminobu Sugaya (UCF)
• 9:25 - 10:00 - Navigating Upcoming Regulatory Changes & EUDAMED Readiness - Mattias Fink & Akra Team

Networking Coffee & Snack Break - 10:00am - 10:15am

• 10:15 - 10:55 - Turning Medical Device Innovation into Regulatory Confidence - Clinical Evidence - Ming Xu - SGS
• 10:55 - 11:40 - FDA Session #1 - ASCA Program - Erica Franca, Director of the Conformity Assessment Program
• 11:40 - 11:45 - Speaker Transition
• 11:45 - 12:15 - AI, Cybersecurity & Software as a Medical Device (SaMD) - Gonda Lamberink - SGS

Networking Lunch - 12:15pm - 1:00pm

• 1:00 - 1:30 - Executive Industry Perspective: Regulatory Leadership at Johnson & Johnson
• 1:30 - 1:35 - Speaker Transition
• 1:35 - 2:05 - Commercialization by Design: From Innovation to Market - Jorge Pastrana | KOEIA BASE
• 2:05 - 2:10 - Speaker Transition
• 2:10 - 2:40 - Digital Transformation in MedTech: The Future of Regulatory Affairs - Amra Racic - Veeva MedTech

Networking Coffee & Snack Break - 2:40pm - 2:55pm

• 2:55 - 3:40 - FDA Session #2 - QMSR & Inspection Priorities - Karen Cruz Arenas
• 3:40 - 3:45 - Speaker Transition
• 3:45 - 4:20 - RAPS
• 4:20 - 4:25 - Speaker Transition
• 4:25 - 4:55 - The Reviewer in the Loop: The Human Element Behind Faster Reviews - Jim Kleinedler - Medtronic
• 4:55 - 5:00 - Speaker Transition
• 5:00 - 5:45 - Executive Leadership Panel: The Future of MedTech Innovation - FDA | Johnson & Johnson | Medtronic | Veeva MedTech | SGS | Akra Team
• 5:45 - 6:00 - Audience Q & A, Closing Remarks & Next Steps

Networking Reception & Innovation Lounge (Together with Plug & Play Innovation Lounge) - 6:00pm - 7:30pm

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