Certhub has completed a funding round of €6.2 million. The Munich-based company Startup The company is developing an AI-powered software platform that digitizes and automates regulatory processes for medical devices. Cusp Capital led the funding 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 new capital, Certhub aims to solve a key bottleneck in the medtech industry: complex and time-consuming approval processes. Currently, manufacturers need an average of five years to bring a medical device to market. The high documentation and compliance burden stifles 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 on documentation time and costs.
Leon Kobinger, co-founder and CEO of Certhub, says:
“Our mission is to remove the regulatory bottlenecks that are slowing down 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 medical device manufacturers. Ultimately, this means that life-changing medical technologies will reach patients sooner.”
Expansion in Europe and beyond
Investors also see great potential. Carolin Althoff, General Partner at Cusp Capital, explained:
“What convinced us most is the team behind Certhub. CEO Leon Kobinger brings practical experience from safety-critical industries such as aviation and has himself led certification processes as an auditor. Combined with the strong engineering of CTO Nicolas Gehring, this gives Certhub a rare credibility to modernize digital compliance and enable products to reach market faster without compromising regulatory stringency.”
Users of the platform include, among others, Oped GmbH. Stefan Kieslinger, Head of Quality Management, confirms:
“Seeing all our regulatory information in one model is a huge step forward. Certhub allows us to focus on data quality instead of formatting dozens of documents. With the analyzer, we can always be sure that all tech document data is accurate and complete. Ultimately, the time we save and the ability to manage product families so easily makes a tremendous difference for our team.”
Certhub plans to use the funding to scale its platform across Europe, expand interfaces with notified bodies in the medical technology sector, and develop jurisdiction packages for markets such as the US and China. In the long term, the startup aims to create a shared compliance infrastructure for manufacturers and testing laboratories.
