MedStart: Regulatory Basics for Medical Startups

The Sacramento region boasts a thriving medical startup ecosystem, and MedStart is dedicated to fostering innovation in the medical and life sciences sectors.

This month, we’re excited to welcome Natalie Vollrath, Senior Regulatory Consultant at MEDIcept, as our guest speaker. Natalie will lead a 45-minute workshop on “Regulatory Basics for Medical Startups.”

In this session, Natalie, a regulatory expert with over 30 years of experience in the medical device industry, will provide an overview of the critical regulatory frameworks startups must navigate. Attendees will gain insights into FDA classifications, ISO standards, and compliance requirements for medical devices, diagnostics, and software. Natalie will guide participants through the essential steps for preparing regulatory submissions, meeting product registration requirements, and ensuring compliance in both U.S. and international markets.

Having led ISO and FDA compliance efforts and contributed to successful product introductions, Natalie will share her expert advice on determining regulatory pathways, preparing documentation, and avoiding common regulatory pitfalls. Whether your startup is just beginning or already developing products, this workshop will equip you with the knowledge to meet regulatory standards and advance with confidence.