AI-powered medtech startup Klaris has raised a $1m (£730,000) funding round in support of its automated regulatory compliance platform for medical device companies.
The London-based startup was founded to address the challenges of securing regulatory approval for new medical devices.
Analysis from the FDA in the US found that 69% of devices are rejected on their first submission for approval.
Klaris aims to address this by automating the development of technical documentation, significantly speeding up the journey to regulatory authorisation for medical equipment manufacturers.
“I spent 10 years building a wearable that detects epileptic seizures – technology that saves lives,” said Klaris co-founder and chief executive Francesco Corazza.
“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 pre-seed funding round was led by Meridian Health Ventures, a specialist fund supported by Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital, University College London Hospitals, and Cedars-Sinai Medical Center.
“Regulatory compliance has become a defining constraint in medtech, with rising MDR and FDA complexity only exacerbating approval bottlenecks,” said Madhav Mahendra, principal at Meridian Health Ventures.
“At Meridian Health Ventures, we believe AI-native reg tech 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.”
Additional funding came from Antler, Vento Ventures, Alecla7, and angels.
