Certhub has closed a funding round of €6.2 million. The Munich startup develops an AI-powered software platform that digitalizes and automates regulatory processes for medical devices. Cusp Capital led the round. D11Z, Calm/Storm, UnternehmerTUM, and nine business angels also participated, including Adrian Kapalis, founder of Kyon Energy, and Axel Stepken, president and former CEO of TÜV SÜD.
With the fresh capital, Certhub aims to solve a central bottleneck in the medtech industry: complex and time-intensive approval procedures. Today, manufacturers take an average of five years to bring a medical device to market. The high documentation and compliance burden slows innovation across the entire sector.
AI against regulatory bottlenecks
Certhub’s platform automates key tasks such as creating technical documentation, maintaining quality management systems, and preparing for audits. Structured approval models replace manual, fragmented workflows. According to the company, customers can save up to 60 percent of documentation time and costs.
Leon Kobinger, co-founder and CEO of Certhub, says:
“Our mission is to eliminate the regulatory bottlenecks that slow medical innovation. With the support of Cusp Capital and our other investors, we can accelerate our vision of making certifications faster, more predictable, and more accessible for medtech manufacturers. Ultimately, this means that life-changing medical technologies reach patients sooner.”
Expansion across Europe and beyond
Investors also see great potential. Carolin Althoff, general partner at Cusp Capital, explains:
“What convinced us most is the team behind Certhub. CEO Leon Kobinger brings practical experience from safety-critical industries such as aviation and has personally led certification processes as an auditor. Combined with strong engineering from CTO Nicolas Gehring, this gives Certhub rare credibility to modernize digital compliance and enable products to get to market faster without compromising regulatory rigor.”
Users of the platform include, among others, Oped GmbH. Stefan Kieslinger, head of quality management, confirms:
“Being able to see all our regulatory information in one model is a huge step forward. Certhub enables us to focus on data quality instead of formatting dozens of documents. With the Analyzer, we’re always confident that all tech doc data is correct and complete. Ultimately, the time we save and the ability to manage product families so easily makes an enormous difference for our team.”
Certhub plans to use the funding to scale its platform across Europe, expand interfaces with notified bodies in medtech, and develop jurisdiction packages for markets like the USA and China. Long-term, the startup aims to establish a shared compliance infrastructure for manufacturers and inspection bodies.
