London-Based Klaris Secures $1M Funding In Pre Seed Round

The funding round was led by Meridian Health Ventures backed by Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital, University College London Hospitals and Cedars-Sinai Medical Center, with participation from existing investor Antler, Vento Ventures, Milan-based Alecla7 and a group of MedTech and regulatory-focused angel investors.

The global medical device market is expected to surpass $1.1 trillion by 2034, yet regulatory requirements remain a major hurdle for companies bringing products to market. FDA analysis shows many 510(k) submissions contain quality deficiencies with a significant number rejected at the first submission stage.

In Europe, tougher MDR and IVDR rules have caused manufacturers to cut back on research and development, leading to fewer medical devices being available on the EU market.

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Klaris addresses these challenges with AI-powered software that automates compliance and consistency checks across technical documentation. The platform helps teams identify gaps, maintain regulatory alignment and prepare submissions and audits efficiently. By combining AI analysis with expert-validated frameworks, Klaris replaces manual documentation processes, enhancing traceability, data security, and overall product lifecycle efficiency.

Founded by Francesco Corazza and Mihai-Sorin Dobre, Klaris leverages deep expertise in medical technology regulatory processes, and AI systems. The new funding will enable the company to expand its engineering and product teams and accelerate commercial growth across the EU, building on early traction in the UK and Italy.

About Klaris

Klaris supports medical device teams in reviewing regulatory documentation before submissions and audits. By providing an AI-powered second opinion, the platform identifies gaps, ensures compliance, and streamlines the review process. Designed by industry experts, Klaris helps manufacturers reduce risk, save time and improve efficiency across the regulatory lifecycle.