Klaris develops software that uses artificial intelligence to analyse and automate compliance and consistency checks across medical-device technical documentation, helping manufacturers identify gaps, stay aligned with MDR, IVDR and FDA requirements, and prepare submissions and audits. By replacing manual processes with automated workflows, the platform improves traceability, data security and efficiency throughout the product lifecycle. Founded by Francesco Corazza and Mihai-Sorin Dobre, the London-based startup has already gained initial commercial traction in the UK and Italy. Klaris plans to leverage its regulatory framework library and expert validations to expand across the wider EU market, where growing compliance demands are squeezing device availability and R&D budgets. The company’s addressable market is large: the global medical-device sector is projected to top $1.1 trillion by 2034, yet a high proportion of 510(k) submissions still suffer quality deficiencies. Klaris recently secured $1 million in pre-seed funding, giving it capital to scale its engineering and product teams and accelerate European expansion. No revenue or user figures were disclosed in the article.

Total raised

$1M

Funding rounds

1

Latest round

Seed

Latest activity

Feb 2026