CertHub raises €6.2M to transform MedTech compliance with AI-driven automation Munich-based medtech manufacturing compliance startup CertHub,has raised €6.2 million in investment in just two months.
Across Europe, medtech companies are facing unprecedented regulatory pressure. 70 per cent of manufacturers report significant struggles with regulatory burden, and implementing new medical regulatory requirements alone is estimated to cost the industry €12 billion.
Obtaining market approval for a medical device today takes an average of 5 years and costs companies more than €4 million in compliance and documentation labour — a structural bottleneck slowing innovation across the entire sector.
CertHub’s AI-first approach directly addresses this inefficiency: proven customer success have shown that manufacturers save up to 60 per cent on documentation time and cost, creating a €2.4 million saving potential per certification cycle.
CertHub’s platform automates key regulatory processes, including technical documentation generation, quality management system documentation, and audit preparation.
By replacing fragmented manual workflows with structured regulatory models and intelligent automation, the platform enables manufacturers to focus on cutting-edge innovation rather than paperwork. Notified Bodies benefit from higher documentation quality, standardised formats, and faster review cycles.
The round was led by Cusp Capital, with participation from D11Z, Calm/Storm, UnternehmerTUM, and nine prominent business angels, including, e.g. Axel Stepken (President and former CEO of TÜV SÜD).
“Our mission is to remove the regulatory bottlenecks that hold back medical innovation,” shared Leon Kobinger, co-founder and CEO of CertHub.
“With the support of Cusp Capital and our other investors, we can accelerate our vision of making certification faster, more predictable, and accessible for manufacturers and Notified Bodies. Ultimately, this means life-changing medical technologies reach patients sooner.”
Dr Carolin Althoff, GP from Cusp Capital, shared:
“What convinced us most is the team behind CertHub. CEO Leon Kobinger brings first-hand experience from safety-critical industries like aviation and has led certification processes himself as an auditor.
Combined with strong engineering from CTO Nicolas Gehring, this gives CertHub a rare credibility to modernise digital compliance and enable products to reach the market faster without compromising regulatory rigour.“
With this new funding, CertHub will scale its platform across Europe, extend its integrations with Notified Bodies, and develop jurisdiction packs for markets such as the USA and Brazil.
Long-term, CertHub aims to build the first shared compliance infrastructure connecting manufacturers and Notified Bodies — and ultimately create the world’s most valuable dataset on certification outcomes, enabling predictive compliance and data-driven product approvals.
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