London based Klaris is positioning itself at the intersection of artificial intelligence and medical regulation as it looks to modernise one of the most complex and risk sensitive processes in healthcare innovation. The medtech startup has secured $1 million in pre seed funding to accelerate the development of its AI driven compliance platform, at a time when regulatory pressure is increasingly shaping how and where medical devices are brought to market.
Funding to tackle regulatory friction in medtech
The funding round was led by Meridian Health Ventures, a specialist healthcare 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 joined the round, alongside Vento Ventures, Milan based private investment firm Alecla7, and a group of angel investors with deep expertise in medical devices and regulatory affairs.
The capital will be used to scale Klaris’ engineering and product teams and to support its commercial expansion across the European Union, building on early traction in the UK and Italy.
A growing market facing mounting compliance hurdles
The global medical device market is expected to surpass $1.1 trillion by 2034, driven by ageing populations, advances in digital health, and rising demand for diagnostics and therapeutic technologies. However, regulatory complexity has become a major bottleneck for innovation.
In the United States, FDA data shows that a significant proportion of 510(k) submissions contain quality deficiencies, leading to frequent rejections at first review. In Europe, the introduction of stricter Medical Device Regulation and In Vitro Diagnostic Regulation frameworks has increased compliance costs and timelines. Many manufacturers report reduced research and development investment and a shrinking number of devices available on the EU market as a result.
Automating compliance with AI
Klaris was founded to address these challenges directly. The company develops AI powered software that automates regulatory compliance and consistency checks across medical device technical documentation. Instead of relying on manual reviews and fragmented workflows, teams can use Klaris to identify documentation gaps, ensure alignment with regulatory requirements, and prepare more robust submissions for audits and approvals.
The platform combines AI driven analysis with expert validated regulatory frameworks, allowing manufacturers to replace traditionally labour intensive documentation processes with a more structured and traceable approach. This helps improve efficiency, reduce errors, and strengthen data security across the product lifecycle.
Founders bridging regulation and technology
Klaris was founded by Francesco Corazza and Mihai Sorin Dobre, who bring complementary backgrounds spanning medical technology, regulatory processes, and AI systems. Their experience informed the company’s focus on building tools that reflect real world regulatory expectations while remaining practical for product and quality teams under time pressure.
By embedding regulatory intelligence directly into software, Klaris aims to make compliance a continuous process rather than a last minute hurdle before submission.
Expanding across Europe
With fresh funding in place, Klaris plans to deepen product capabilities and expand its presence across the EU, where regulatory complexity is particularly acute. The company sees strong demand from small and mid sized medical device manufacturers that lack the resources to maintain large in house regulatory teams but still need to meet rigorous standards.
As regulators continue to raise the bar on safety, traceability, and documentation quality, Klaris is betting that AI driven compliance infrastructure will become a core requirement for medtech companies looking to innovate at speed without compromising on regulatory trust.
