Klaris will use the funding to scale its engineering and product teams and accelerate commercial expansion into the wider EU market, following initial traction in the UK and Italy.
London-based Klaris, an AI-driven medtech startup focused on automating regulatory compliance for medical device companies, has closed a $1 million pre-seed funding round. The round was led by Meridian Health Ventures, a specialist fund backed by Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital, University College London Hospitals, and Cedars-Sinai Medical Center. Existing investor Antler also participated, alongside Vento Ventures, Milan-based private investment firm Alecla7, and a group of MedTech and regulatory-focused angel investors.
The medical device market is projected to exceed $1.1 trillion by 2034, while regulatory requirements continue to present significant challenges for companies bringing products to market. According to FDA analysis, a large share of 510(k) submissions include quality deficiencies, and many are rejected at the first submission stage.
In Europe, increasing regulatory demands linked to MDR and IVDR requirements have also led manufacturers to report reduced research and development activity, alongside a decline in the number of devices available on the EU market.
To address these regulatory challenges, Klaris develops AI-powered software designed to support compliance for medical device manufacturers. Its platform automates compliance and consistency checks across technical documentation, helping teams identify gaps, maintain alignment with regulatory requirements, and prepare for submissions and audits.
By combining AI-driven analysis with expert-validated regulatory frameworks, the company aims to replace traditionally manual documentation processes with a more streamlined approach, improving traceability, data security, and efficiency throughout the product lifecycle.
The company was founded by Francesco Corazza and Mihai-Sorin Dobre, combining experience in medical technology, regulatory processes, and AI systems.
With the new funding, Klaris will scale its engineering and product teams and accelerate commercial expansion into the wider EU market, following initial traction in the UK and Italy.