Klaris, a regulatory compliance automation startup for medical device companies, has raised £750,000 in a pre-seed round led by Meridian Health Ventures, with participation from Antler, Vento Ventures, and Alecla7. It develops software that automates the creation of regulatory technical documentation, helping manufacturers identify compliance gaps before submission. The funding will be used to scale engineering and product teams and support commercial expansion into the wider EU market following initial traction in the UK and Italy.
Regulatory approval remains a significant barrier for medical device manufacturers, with most submissions containing quality deficiencies and many rejected at first review. In Europe, compliance requirements have led some manufacturers to reduce research and development activity, while thousands of devices have been removed from the market. Klaris addresses this by automating documentation development, replacing slow manual processes and enabling manufacturers to bring new devices to patients more quickly.
Francesco Corazza previously spent over a decade at Empatica, where he scaled the team and led the product behind multiple FDA clearances, including the first FDA-cleared seizure detection wearable. Mihai-Sorin Dobre holds a PhD in AI decision-making from the University of Edinburgh and led planning and prediction research at Five AI, which was later acquired by Bosch.
I spent 10 years building a wearable that detects epileptic seizures - technology that saves lives. But I watched it sit in regulatory limbo while we wrangled through hundreds of pages against regulations that even experts interpret differently. The industry keeps building better ways to manage that paperwork instead of eliminating it. That's what we're fixing.
Francesco Corazza, Co-founder & CEO
Regulatory compliance has become a defining constraint in MedTech, with rising MDR and FDA complexity only exacerbating approval bottlenecks. At Meridian Health Ventures, we believe AI-native RegTech platforms will become universal infrastructure for the industry, augmenting existing consultant-led workflows, accelerating procurement processes, and reducing friction at the regulator level. Klaris stands out not only for the exceptional team, but for their approach: detecting gaps and generating compliant content with a level of speed, accuracy, and cost efficiency that fundamentally changes how quickly and efficiently devices get to market. As a unique NHS-anchored fund embedded inside leading transatlantic health systems, we look forward to supporting Klaris growth with a powerful platform to scale across Europe and US.
Madhav Mahendra, Principal at Meridian Health Ventures
The most successful startups are built by founders who use AI to solve problems they’ve faced firsthand. This is a formidable founding team with deep domain expertise solving one of the industry’s most critical bottlenecks. By automating the complex, manual burden of regulatory compliance, Klaris is not just improving business efficiency; they are ensuring that life-saving medical innovations can reach the patients who need them far more quickly. We are proud to continue our support as they scale this essential technology across Europe.
Jed Rose, Partner at Antler
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