Klaris raises pre-seed to automate compliance docs, speed device approvals using AI
This article covers Klaris, a healthtech startup, which has closed a £880k pre-seed funding round to commercialise software that automates regulatory technical documentation for medical device makers. The raise aims to help medical device manufacturers identify compliance gaps earlier and speed approvals, targeting persistent regulatory bottlenecks in medtech.
Klaris, a healthtech startup, has closed a £880k pre-seed funding round to commercialise software that automates regulatory technical documentation for medical device makers. The raise aims to help manufacturers identify compliance gaps earlier and speed approvals — a practical response to persistent regulatory bottlenecks in medtech.
Why it matters
Regulatory approval remains a major barrier for medical device manufacturers. Many submissions contain quality deficiencies and are rejected at first review, and tighter requirements under recent MDR updates have led some firms to scale back R&D or withdraw devices from the market. Automating documentation and gap detection could reduce review cycles and lower the operational cost of compliance, making it easier for innovators to reach patients.
Inside the product
Klaris builds software that automates the creation of regulatory technical documentation and flags compliance gaps before submission. The company says this replaces slow, manual processes that typically rely on consultant-heavy workflows and large volumes of paperwork.
The team reports initial commercial traction in the UK and Italy. The new funding will be used to expand engineering and product teams and to support a wider roll-out across the EU.
Who are the investors?
Klaris’ pre-seed was led by Meridian Health Ventures, with participation from Antler, Vento Ventures and Alecla7. Meridian is presented as an NHS-anchored fund with transatlantic health system links; Antler is a global early-stage investor known for backing founder-led teams. The investors' rationale focuses on automating regulatory workstreams and using AI to reduce time-to-market for medical devices.
In the announcement, Madhav Mahendra, Principal at Meridian Health Ventures, said:
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.
In the announcement, Jed Rose, Partner at Antler, said:
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.
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Founder perspective
Klaris was co-founded by Francesco Corazza and Mihai-Sorin Dobre. Corazza spent more than a decade at Empatica, where he scaled teams and led product work behind multiple FDA clearances, including the first FDA-cleared seizure detection wearable. Dobre holds a PhD in AI decision-making from the University of Edinburgh and led planning and prediction research at Five AI, a team later acquired by Bosch. Those experiences inform Klaris’ focus on combining domain and regulatory knowledge with AI.
In the announcement, Francesco Corazza, Co-founder & CEO at Klaris, said:
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.
The bigger picture
Klaris’ raise sits within a wider trend of startups applying AI to regulatory workflows in healthtech. Investors are increasingly looking for tools that reduce dependence on expensive external consultants and cut time from prototype to patient-ready product. If automated documentation and gap detection prove reliable under scrutiny, regulators and manufacturers could both benefit from fewer review cycles and clearer dossiers.
For the UK and Europe, solutions that lower regulatory friction are particularly timely as firms navigate both MDR enforcement and divergent post‑Brexit regulatory pathways. Klaris’ EU expansion plans reflect a demand for practical compliance tools across national markets, and the round highlights continuing investor appetite for founders combining medtech experience with AI expertise.
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