Nilo Medical Consulting Group

Nilo Medical Consulting Group (NMCG) is a regulatory consulting and clinical research organization founded in 2016, specializing in medical devices, pharmaceuticals, and biotechnology products. The firm supports companies from early concept development through global market entry, offering services across the full product lifecycle including design, manufacturing, and commercialization phases.

NMCG provides regulatory strategy and submissions (510(k), De Novo, PMA, IDE), full-service CRO capabilities including clinical trial management and monitoring, quality system development aligned with 21 CFR 820 and ISO 13485, and product lifecycle support including design controls and risk management. The team includes former FDA staff and experienced industry professionals who facilitate agency interactions and secure designations such as Breakthrough Device and STeP.

The firm has supported numerous FDA clearances including participation in the first device cleared through the FDA's Safer Technologies Program. NMCG serves clients ranging from startups to established global firms across US, EU, and international markets, operating as a boutique CRO with flexible service offerings tailored to client needs.

Choose NMCG when you need regulatory expertise combined with clinical trial execution capabilities under one roof, particularly for complex medical device pathways requiring FDA interaction strategy. Their boutique approach offers personalized attention and flexibility that larger CROs may not provide, with the credibility of former FDA staff informing regulatory decisions.

Expect a collaborative partnership model where NMCG integrates with your team rather than operating as a distant vendor. Their experience with novel regulatory pathways like Breakthrough Device designation makes them particularly valuable for innovative products requiring strategic agency engagement.

NMCG exclusively serves the healthcare sector with specialization in medical devices, combination products, pharmaceuticals, and biotechnology. Their expertise centers on FDA regulatory compliance including 21 CFR 820 quality systems, ISO 13485 medical device standards, and ISO 14971 risk management requirements.

The firm supports healthcare innovators across therapeutic areas with particular strength in SaMD (Software as a Medical Device) and digital health regulatory strategy. Their services address the specific regulatory and clinical requirements of bringing medical products to market while ensuring patient safety and post-market surveillance compliance.

Medical device companies at any stage from pre-IDE through post-market requiring integrated regulatory and clinical support. Ideal clients value personalized service and strategic guidance over commodity CRO services, particularly those pursuing innovative regulatory pathways, first-time FDA submissions, or needing quality system development alongside regulatory strategy for devices in US and international markets.