QARAlink

Global compliance. Smarter, Stronger, Faster.

QARAlink is a Swiss regulatory-intelligence startup founded in 2024, helping MedTech and HealthTech teams turn complex, fast-changing requirements into clear, actionable decisions. Our AI-supported, human-centered platform brings scattered regulations, guidance and internal evidence into one structured, collaborative workspace so Regulatory Affairs, Quality and Compliance teams can plan proactively, reduce rework, and maintain audit-ready documentation across global pathways.

Built for MDR, IVDR, SaMD and FDA workflows and expanding to emerging AI and global regulations, QARAlink is designed to shorten time-to-market and make compliance a strategic advantage. Backed by business angels, VCs, partners and public support, we raised USD 936k in pre-seed funding (Aug 2025) to accelerate product development and scale our growing team. With traction in Europe and the US, we’re on a mission to help innovators bring life-changing technologies to patients faster, with confidence.