CertHub

AI-powered compliance management for medical devices

MISSION

To digitise and standardise regulatory compliance by replacing fragmented manual workflows with a shared, data-driven infrastructure for regulated industries.

TEAM

CertHub is led by Leon Kobinger and Nicolas Gehring, combining deep MedTech and software expertise. Leon is a medical engineer with over 11 years in regulated industries. Nicolas is an AI-focused computer scientist and former early engineer at Avelios Medical and Capmo. The team is complemented by senior leaders in growth, regulatory affairs, and quality management.

PROBLEM

MedTech certification is fragmented, manual and slow, causing multi-year timelines, higher costs, delayed market access and significant bottleneck for medical innovation.

SOLUTION

CertHub is a unified, cloud-based compliance platform for manufacturers and notified bodies. It uses AI and structured regulatory data to automate technical documentation, conformity assessments, clinical evaluations, and audits. Real-time collaboration in one system replaces manual workflows and serves as the digital backbone for medical device certification.

FOUNDER QUOTE

C/S 2
Health Backend
AI

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