CEO Mangold Consultants
MedTech Market Access, Regulatory Strategy Expert
Niko Mangold is a regulatory strategist, MedTech expert, and lecturer with a passion for guiding health innovation safely to market. With over 40 successful international regulatory projects, Niko supports startups, scale-ups, and global manufacturers in navigating complex frameworks in the healthtech field.
He currently leads regulatory affairs for EMEA at SprintRay, serves as a technical assessor for QS International, and lectures on regulatory strategy. His consulting focus lies in Software as a Medical Device (SaMD), AI/ML compliance, and accelerating market access without compromising safety.
As founder of Mangold Consultants, Niko has helped build compliant quality systems, optimize clinical evaluation strategies, and support regulatory readiness in markets across Europe, North America, the Middle East, and beyond. His work bridges regulation and innovation — enabling next-generation technologies to enter the market with clarity, speed, and integrity.
Niko Mangold is a Member of the Board of Ambassadors of THE HEALTH CAPTAINS CLUB.
“I joined the Health Captains Club to help create a better healthcare system. As a regulatory strategist, I believe that better health outcomes require not just great ideas, but also the right frameworks to bring them to life — safely, ethically, and globally. Being a Health Captain means shaping that future together.”
NIKO MANGOLD
Managing Partner of Mangold Consultants
Member of the Board of Ambassadors of THE HEALTH CAPTAINS CLUB