Southern California LNG In Person Event: Regulatory Considerations for Medical Device Start-up Companies

Explore regulatory strategies for medical device start-ups, including FDA pathways, early planning, and building effective quality systems.

Launching a medical device start-up requires more than a great idea—it requires a thoughtful regulatory strategy from the beginning. Sponsored by MDSS and in partnership with Hologics and PRN Medical, this event will explore key regulatory considerations for early-stage medical device companies, including selecting the appropriate FDA pathway and preparing for regulatory submissions and global market entry.

Industry experts will share practical insights and lessons learned to help founders, innovators, and start-ups navigate regulatory challenges while supporting product development and commercialization. Attendees will gain valuable perspectives on regulatory strategy, global market access, and compliance considerations essential for successful product development.

Agenda

5:00-5:30           Registration & Networking
5:30-5:40           Welcome and Introduction
5:40-6:20           Panel 1: Regulatory Strategy
6:20-6:40           Networking Break
6:40-7:20           Panel 2: How to avoid common errors?
7:20-7:30           Wrap-up

Location:

Hologics GCD 1-Auditorium
10210 Genetic Center Drive
San Diego, CA 92121

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected]

Panelists

Heinz  Steneberg

Heinz Steneberg

President & CEO, MDSS USA

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Charla  Triplett

Charla Triplett

Head of Strategy, Partnerships & Growth, University Lab Partners

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Robert  Genthert

Robert Genthert

Managing Partner, EvoNexus

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Ludger  Moeller

Ludger Moeller

Founder & Owner, MDSS GmbH

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Shep  Bentley RAC

Shep Bentley RAC

Principal Consultant, Benley Biomedical Consulting LLC

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Coco Oxford

Coco Oxford

COO, PRN Medical

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Sponsors

Gold 

Bronze 

 

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