What does Hardian Health do?

Hardian Health is a UK-based clinical digital consultancy firm that specializes in Software as a Medical Device (SaMD) and AI medical devices (AIaMD). Founded in 2018 and operating under Hardian Limited since 2019, the company is located in Haywards Heath, West Sussex. With a team of approximately 8-15 employees, Hardian Health provides comprehensive consultancy services that include regulatory consulting, clinical evaluation, health economics modeling, and intellectual property services. The firm supports healthtech innovators by helping them navigate regulatory pathways, including CE-mark and FDA clearance processes. They have developed HaRi, a global regulatory intelligence database designed to aggregate medical device data for industry use. Hardian Health collaborates with various healthtech companies, such as MyCardium AI and Prof.Valmed®, to facilitate the regulatory success of AI-driven medical solutions. Their focus is on advancing the AI medical device sector through clinical research and regulatory science.