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.
Date: January 15, 2024
Time: 6 pm - 8 pm
Cost: $5
Register: Startup Grind
About Natalie Vollrath
Natalie Vollrath brings over 30 years of experience as a quality and regulatory professional in the medical device industry. She has broad experience across multiple product categories and device classes, preparing regulatory submissions and obtaining product registrations for U.S and international markets. Natalie has led ISO and FDA regulatory and compliance efforts throughout the product lifecycle and played a key role in new product introductions.
As a Sr. Regulatory Consultant at MEDIcept, Natalie assists clients with their regulatory needs, including determination of the regulatory pathways for US, EU, and other international markets, developing and preparing submissions, technical files, Pre-Submission meeting requests, non-filing justifications, and other regulatory documentation and activities.
Before joining MEDIcept, she held roles including Quality Assurance/Regulatory Affairs Manager at various companies in the medical device industry, working with a diverse range of products that included Software as a Medical Device (SaMD) and Software as a Service (SaaS).
Natalie holds a B.A degree from the University of California, San Diego as well as certificates in Systems Engineering and Biostatistics. She is Regulatory Affairs Certified through the Regulatory Affairs Professionals Society (RAPS). Natalie also holds several additional certifications through ASQ, including Certified Medical Device Auditor, Certified Quality Engineer, and Certified Software Quality Engineer.