About Us
Founded in 2016, Nilo Medical Consulting Group, LLC (NMCG) provides expert regulatory consulting and clinical research services to companies developing medical devices and combination products. We work with organizations of all sizes—from startups to established global firms—across the US, EU, and other key markets. Whether you're in the design, manufacturing, or commercialization phase, we offer strategic guidance backed by deep regulatory and clinical expertise.
Our team brings decades of combined experience in global regulatory submissions, product development, quality systems, and clinical trial management. Supported by a network of former FDA staff and seasoned industry professionals, we ensure every client benefits from insight, precision, and credibility.
Our Mission
To help clients navigate the regulatory and clinical landscape in a way that is personal, successful, and efficient at competitive rates.
Niche Expertise. Tailored Solutions.
Our strength lies in crafting customized, compliant, and forward-thinking solutions. With a client-first mindset and multidisciplinary background, we understand the complexities of your industry and work to meet your specific regulatory and clinical goals—no matter where you are in the product lifecycle.
Collaborative Approach
We don’t just consult—we collaborate. At NMCG, we partner closely with your team, providing clear, actionable guidance and empowering you to move forward confidently in a shifting regulatory landscape.
Proven Success
Our results speak for themselves. NMCG has helped clients secure numerous 510(k) and De Novo clearances, as well as Breakthrough Device and STeP designations. We played a key role in the first device cleared through the FDA’s Safer Technologies Program and have successfully designed and conducted clinical trials across multiple therapeutic areas. As a boutique CRO, we offer full-service trial support with the flexibility to tailor our services to your specific needs.
Our Services Include:
Comprehensive regulatory strategy development
FDA interactions (informal outreach, Q-submissions)
Breakthrough and STeP designation guidance
Premarket submissions: 510(k), De Novo, PMA, IDE
Boutique CRO services and full clinical trial support
Risk management and design control development
Regulatory and quality guidance for SaMD and digital health
Product development support with a regulatory and quality lens
International regulatory strategies and Notified Body coordination