London-based Klaris raises $1 million to automate regulatory compliance for MedTech innovators

While the medical technology sector continues to pioneer life-saving solutions, the path to market is becoming increasingly challenging due to complex regulatory frameworks, such as the EU Medical Device Regulation (MDR).

Klaris, founded by Francesco Corazza and Mihai-Sorin Dobre, provides an AI-native platform aimed at alleviating this bottleneck. The system automates the verification of technical files, identifying discrepancies and ensuring alignment between internal documentation and evolving regulatory standards. Leveraging expert-validated frameworks, the platform offers precise gap analysis and consistency checks, enabling quality assurance teams to maintain high-integrity records without the manual burden of traditional workflows.

The start-up recently secured $1 million in pre-seed funding, led by Meridian Health Ventures and with participation from existing investors including Antler, Vento Ventures and Alecla7. Klaris plans to use the funding to expand its engineering capabilities and increase its presence across the EU.

Sources: Klaris | Crunchbase

Founders: Francesco Corazza, Mihai-Sorin Dobre