Klaris secures $1M to automate medtech regulatory work
London-based AI startup Klaris has raised a $1 million pre-seed round led by Meridian Health Ventures, an NHS-backed investor, as the company targets one of medtech’s biggest bottlenecks: regulatory documentation.
The funding will support development of Klaris’ platform designed to automate and standardize the creation of regulatory documents used in submissions to the U.S. Food and Drug Administration (FDA) and under the European Union’s Medical Device Regulation (MDR). By reducing manual drafting and review cycles, the startup says it can help companies cut delays that often slow device launches and keep innovations from reaching patients.
Addressing a costly, slow-moving process
Regulatory preparation is frequently cited by medtech teams as a major source of time and expense, particularly as requirements evolve and documentation must be updated across multiple markets. Klaris is positioning its AI tooling as a way to streamline compliance workflows, improve consistency, and reduce rework during audits and submission reviews.
Why investors are paying attention
Backers see growing demand for software that can modernize compliance-heavy healthcare operations. With Meridian Health Ventures leading the round, the startup gains not only capital but also strategic proximity to the UK’s healthcare ecosystem—an advantage as it validates its product with medtech stakeholders.
The company’s stated goal is a faster path from development to clearance, ultimately enabling quicker access to new devices for patients by minimizing avoidable regulatory delays tied to documentation.
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