QARAlink Raises USD 936,000 Pre‑Seed to Modernize Regulatory Intelligence for MedTech

The Vaud-based startup introduces an AI‑supported, human‑centered platform that turns regulatory knowledge into actionable go-to-market strategy, already serving EU and US markets, covering MDR, IVDR, FDA and emerging AI regulations.

QARAlink, a Swiss startup building an AI-supported regulatory intelligence platform for MedTech and HealthTech companies, has raised USD 936,000 in pre-seed funding at an approx. USD 5.6 million valuation. Backed by business angels, venture capital, partners and government grants, the round will accelerate QARAlink’s mission to shorten time-to-market by replacing scattered, complex, manual compliance work with a structured, collaborative system that keeps pace with changing global regulations.

Founded in 2024, QARAlink combines regulatory expertise with cutting‑edge AI to capture, structure and operationalize regulatory knowledge. Teams can plan proactively, automate routine checks, and maintain audit-ready evidence, helping them anticipate changes, reduce rework, and move products through MDR/IVDR and FDA pathways with greater efficiency and predictability.

“We’re building QARAlink because regulatory intelligence should be accessible, collaborative and actionable,” said Tom Petty, Co‑founder and CEO of QARAlink. “This round is a vote of confidence in the urgency of the problem and our approach, making compliance not just easier, but smarter and faster, so MedTech innovators can reduce risk, save money, and stay focused on their life-changing products.”

The round combines cash with a portion of in‑kind services from trusted technology partners, aligning resources with QARAlink’s roadmap and early customer traction. Funds will be used to accelerate market entry, boost state-of-the-art AI capabilities, and expand the company’s cross‑functional team across regulatory affairs, data management, and product research and development.

“I invested in QARAlink because they’re not just adding AI, they’re reimagining how humans interact with it. Their platform relieves the burden of navigating complex knowledge, keeping people at the heart of decisions. That’s the kind of future I believe in.” – Anonymous business angel, Switzerland.

“Regulatory work too often lives in scattered documents and tacit know‑how. QARAlink’s structured, AI‑supported approach brings order and speed to a mission‑critical function. The team’s regulatory depth and product discipline convinced me they can execute.” – the kind of future I believe in.” – Anonymous business angel, Canada.

QARAlink will launch the first version of its platform later this year, offering early adopters an AI‑supported, compliance‑ready knowledge system designed to seamlessly integrate, support and empower Regulatory Affairs, Quality Assurance and Compliance teams, reduce friction and make regulatory readiness a strategic advantage.

➡️ Source: Press Release | 📸 ©QARAlink