CertHub Raises €6.2M To Ease MedTech Regulatory Compliance

Across Europe, medtech manufacturers are facing unprecedented regulatory pressure. Around 70% of companies report significant challenges with regulatory burden, while the cost of implementing new medical regulations is estimated at €12 billion industry-wide.

Securing market approval for a medical device takes an average of five years and costs more than €4 million in compliance and documentation labor creating a structural bottleneck that slows innovation across the sector.

CertHub’s AI-first approach directly addresses this inefficiency. Proven customer results show manufacturers can reduce documentation time and costs by up to 60%, unlocking up to €2.4 million in savings per certification cycle.

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The CertHub platform automates core regulatory processes, including technical documentation creation, quality management system (QMS) documentation and audit preparation.

By replacing fragmented, manual workflows with structured regulatory models and intelligent automation CertHub enables manufacturers to focus on innovation rather than paperwork. Notified Bodies benefit from higher-quality documentation, standardized formats and faster review cycles.

The funding round was led by Cusp Capital, with participation from D11Z, Calm/Storm, UnternehmerTUM and nine prominent business angels, including 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 the new funding, CertHub plans to scale its platform across Europe, expand integrations with Notified Bodies and develop jurisdiction-specific compliance packs for markets including the United States and Brazil.

Over the longer term CertHub aims to build the first shared compliance infrastructure connecting manufacturers and Notified Bodies and to create the world’s most comprehensive dataset on certification outcomes, enabling predictive compliance and more data-driven product approvals.

About CertHub

CertHub is a medtech compliance platform that helps bring medical products to patients faster by digitizing and automating regulatory processes. Its AI-powered software streamlines technical documentation, quality management systems and certification workflows reducing regulatory complexity, shortening approval timelines, and enabling manufacturers to focus on innovation rather than paperwork.