SGS Lake Nona MedTech Regulatory Innovation Symposium

Description

SGS Lake Nona MedTech Regulatory Innovation Symposium
October 29, 2026, | GuideWell Innovation Center - 6555 Sanger Rd, Orlando, FL 32827

Join SGS, industry leaders, regulators, innovators and healthcare professionals for a dynamic one-day event at the GuideWell Innovation Center in Orlando, Fl.  Focused on advancing medical technology and providing greater protection for patients, this event features experts from across the medical device industry. 

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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Lake Nona Hotels - Book your Corporate Rate | Plug and Play, LLC

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