CertHub, a company developing an AI-powered platform to streamline medical device certification, has successfully closed an oversubscribed $7.2 million seed funding round. Led by Cusp Capital, the investment aims to tackle the severe regulatory challenges hindering innovation within the European medtech sector. This new capital will empower CertHub to accelerate its mission of making regulatory compliance faster, more predictable, and efficient for manufacturers.
Addressing a Critical Industry Bottleneck
The European medical technology industry is currently grappling with immense regulatory pressure, costing an estimated $14 billion to implement new requirements. For individual companies, obtaining market approval for a new device is a lengthy and expensive process, averaging five years and over $4.7 million. This significant financial and temporal burden creates a structural bottleneck that stifles crucial advancements across the entire sector.
This administrative hurdle directly impacts patient care by delaying the availability of life-saving medical technologies. Manufacturers are forced to divert significant resources away from research and development to manage complex paperwork and compliance tasks. Consequently, the pace of innovation slows, and the gap between a breakthrough discovery and its clinical application widens unnecessarily.
An AI-Powered Solution for Compliance
CertHub's platform directly confronts these inefficiencies with an AI-first approach designed to automate critical regulatory workflows. The system handles tasks such as generating technical documentation, managing quality management systems, and preparing for audits. By replacing fragmented manual processes with intelligent automation, it provides a structured and streamlined path to certification for medtech companies.
The platform delivers substantial and measurable benefits, with customer success stories demonstrating savings of up to 60 percent on documentation time and costs. This efficiency translates to a potential saving of $2.8 million for each certification cycle, allowing manufacturers to reinvest in innovation. Notified Bodies also benefit from receiving higher-quality, standardized documentation, which accelerates their review and approval cycles significantly.
Investor Confidence and Strategic Vision
The funding round was led by Cusp Capital and saw participation from D11Z, Calm/Storm, UnternehmerTUM, and notable business angels like former TÜV SÜD CEO Axel Stepken. Leon Kobinger, co-founder and CEO of CertHub, stated that the investment will accelerate their vision of removing regulatory bottlenecks. This will ultimately ensure that life-changing medical technologies can reach patients much sooner.
Future Plans and Global Expansion
With this new injection of capital, CertHub plans to scale its platform aggressively across the European market. The company will also focus on extending its integrations with Notified Bodies to create a more seamless ecosystem. Furthermore, development is underway for jurisdiction packs to support entry into key international markets, including the United States and Brazil.
Looking ahead, CertHub's long-term ambition is to build the first shared compliance infrastructure that connects manufacturers and regulatory bodies. This network aims to create the world's most valuable dataset on certification outcomes. Such a resource would enable predictive compliance and pave the way for more efficient, data-driven product approvals in the future.
This $7.2 million investment marks a pivotal moment for CertHub and the broader medtech industry it serves. By automating and simplifying the arduous certification process, the company is well-positioned to dismantle long-standing barriers to innovation. The successful funding round not only validates CertHub's approach but also signals a promising shift toward a future where critical medical devices reach the market, and patients, faster.