London-based Klaris, an AI-driven
medtech startup focutilized 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-focutilized 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, supporting 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.
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