From Vision to Validation: How C3 Helped Elira Enter FDA Trials

For founders in the medical device space, innovation isn’t just about what you build — it’s about what you overcome. Regulations. Fundraising. Design complexity. Timing. It’s an emotional, high-stakes journey that demands more than technical know-how; it requires resilience, trust, and a partner who’s in it for the long haul. At C3, we’ve walked that road with innovators who are reshaping healthcare — and one of our most transformative stories comes from our work with Elira.

When Elira approached us, they had a bold concept and a clear mission: to bring their novel medical device to patients through the rigorous FDA approval process. What followed was a multiyear partnership defined by creativity, persistence, and precision. From designing the core electronics to building the mobile app and secure cloud infrastructure, our team engineered every piece needed to meet FDA standards — including data tracking requirements for clinical trials. When regulators introduced unexpected demands, like the creation of sham devices for trial control groups, we adapted quickly, delivering innovative solutions that preserved both trial integrity and patient safety. Throughout delays in funding and supply chain disruptions, C3 remained the thread that kept the project moving forward. We didn’t just build systems — we built momentum.

When it comes to medical innovation, you don’t just need code. You need a collaborator who understands what’s at stake. At C3, we help turn breakthrough ideas into FDA-ready realities — navigating regulation, architecture, and uncertainty with equal care. If you’re building something that could change lives, you deserve a partner who knows how to get it over the finish line. Let’s talk about how we can help.

Craig Carder

President/Egineering Principal

Eydis Lima

Project Engineering Lead
Engineering Sales

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