Case Studies
Regulatory Studies
Breaking Barriers: Helping a European MedTech Startup Enter the U.S. Market
When Amsterdam-based Rosesta Medical set out to launch its over-the-counter (OTC) fertility aid in the U.S., it faced a critical challenge: achieving FDA clearance. While their product had already found success in the European market, entering the U.S. meant navigating a complex regulatory landscape, one with unique requirements for OTC medical devices. That’s where SoundRocket came in.Through a strategic research partnership, SoundRocket led the design and execution of FDA-compliant label comprehension, self-selection, and simulated use studies, tailored specifically for U.S. consumers.The result? Rosesta Medical not only earned the regulatory green light—it did so with confidence in the product’s clarity, usability, and market readiness. This case study offers a behind-the-scenes look at how global innovation meets American compliance standards through scientific rigor and collaboration.