About Us
Founded in 2016, Nilo Medical Consulting Group, LLC provides regulatory consulting services in the medical device and combination product industries. We partner with small to large medical device and biotechnology companies in the design, manufacturing, and/or sales phase of medical device development based in the US, EU, and other geographies. Our team has experience in global submissions, regulatory strategy, interactions with regulatory bodies, product development, quality systems, clinical trials, and more. Our extended network of ex-FDA and industry experts ensures that clients can rely on the quality of our work.
niche exertise, tailored solutions
Our client-centric approach and diverse backgrounds allow us to craft innovative solutions specifically tailored to your industry and regulatory/clinical requirements. Whether you’re a startup or an established company, we have the knowledge and skills to guide you through.
collaborative approach
We believe in partnership. We don’t just provide expertise; we work alongside you, empowering you to navigate the regulatory and clinical landscape with confidence.
proven success
Our track record demonstrates our proficiency in regulatory affairs, product development, and clinical trials. Our work has led to numerous successful 510(k) clearances, De Novo clearances, and Breakthrough Device designations for clients. Our services were instrumental in securing clearance for the first device cleared through the Safer Techologies Program (STeP). We have designed and conducted numerous successful clinical trials and can provide full CRO services and tailored solutions for your clinical investigational endeavors.
Our solutions
Detailed regulatory strategies
Facilitation of FDA interactions via informal outreach or Q-submissions
Breakthrough and STeP Designations
Premarket regulatory submissions (510(k), De Novo, PMA, IDE, etc.)
Boutique CRO services to ensure that clinical trials are well planned and executed
Risk management and design control development and guidance
Assistance with SaMD and Digital Health requirements
Guidance through product development with a regulatory and quality base
International regulatory strategies and facilitation of interactions with Notified Bodies and other OUS regulatory bodies