London-based Klaris has closed a $1 million pre-seed funding round to tackle the regulatory bottlenecks currently stalling the medical device industry. The round was led by Meridian Health Ventures, a specialist fund backed by prominent healthcare institutions including Guy’s and St Thomas’ NHS Foundation Trust and Cedars-Sinai Medical Center, with participation from Antler and Vento Ventures.
The big picture: Bringing a medical device to market has become an operational nightmare. In the U.S., a significant share of FDA 510(k) submissions are rejected due to quality deficiencies, while in Europe, the transition to MDR and IVDR requirements has actually led to a decline in available devices. Klaris addresses this by replacing manual technical documentation with an AI-driven platform that automates consistency checks and audit readiness.
How it works:
- Technical Orchestration: Automates alignment checks across complex technical files to ensure they meet specific regulatory frameworks.
- Gap Analysis: Identifies missing documentation or quality flaws before submission to reduce the risk of rejection.
- Traceability: Improves data security and audit trails throughout the entire product lifecycle.
The catch: While automating “paperwork” is a clear win, Klaris operates in a high-stakes sector where an AI oversight can lead to patient harm or massive legal liability. Much like the challenges in clinical documentation, the “expert-validated” layer of Klaris must be flawless; a hallucination in a regulatory submission isn’t just a typo—it’s a potential compliance failure that could bankrupt a startup. Furthermore, as the platform expands into the wider EU market, it must navigate the notoriously fragmented and shifting interpretations of MDR across different Notified Bodies, a task that often requires the very human, “bespoke” consulting expertise that AI agents struggle to replicate.
Key Details
- Funding: $1M (Pre-Seed)
- Lead: Meridian Health Ventures
- CEO: Francesco Corazza
- Sector: Medtech / RegTech
