At Calm/Storm, we believe some of the most important breakthroughs in healthcare don’t happen in clinics or labs but in the infrastructure that determines whether innovation ever reaches patients at all.

Medical technology is advancing rapidly. AI-driven diagnostics, novel devices, and digital therapies promise better outcomes for millions of patients. Yet across Europe, too many of these innovations stall long before market entry. The limiting factor is no longer scientific ambition. It is regulatory complexity.

That’s why we’re proud to back CertHub, a Munich-based, AI-first compliance platform that is transforming how medical devices are certified and removing one of the biggest bottlenecks in MedTech innovation.

‍

From Regulatory Bottlenecks to Predictable Certification

‍

Bringing a medical device to market has become one of the most complex operational challenges in healthcare. Under MDR and IVDR, teams must navigate thousands of pages of technical documentation, interpret evolving regulatory requirements, coordinate with multiple stakeholders, and do so under immense time pressure and uncertainty.

Today, obtaining market approval for a medical device takes around five years on average and costs companies more than €4 million in compliance and documentation labor alone. Across Europe, 70% of MedTech manufacturers report significant struggles with regulatory burden, and the implementation of new regulatory requirements is estimated to cost the industry €12 billion.

The result is a system defined by fragmentation, manual processes, and unpredictability slowing innovation across the entire sector and disproportionately impacting SMEs.

‍

CertHub fundamentally changes this dynamic.

‍

By replacing document-heavy, siloed workflows with structured regulatory models and AI-driven automation, CertHub turns compliance into a continuous, collaborative, and transparent process. The platform automates key steps such as Technical Documentation generation, Quality Management System documentation, and audit preparation allowing manufacturers to focus on innovation rather than paperwork.

Notified Bodies benefit from standardized formats, improved data quality, and faster, more dependable review cycles. A process that was once opaque and reactive becomes structured, predictable, and scalable. CertHub is creating the operating system that connects both sides of the ecosystem, bringing manufacturers and Notified Bodies together through a fully integrated end to end platform.

‍

A Market at a Breaking Point (and an Inflection Point)

‍

Regulatory compliance is no longer a support function. It has become the defining constraint of the European MedTech ecosystem.

Certification timelines continue to expand, capacity at Notified Bodies remains limited, and rising costs force many manufacturers to delay launches or exit the market altogether. Industry associations increasingly call for standardized, data-driven, and interoperable regulatory workflows.

At the same time, AI has reached production-grade reliability for document automation, structured reasoning, and audit support. For the first time, a system-level solution to regulatory complexity is technically and commercially viable.

CertHub enters the market at precisely this inflection point.

Early customer results show that manufacturers can reduce documentation time and cost by up to 60%, creating a saving potential of €2.4 million per certification cycle. This is not incremental optimisation, it is structural efficiency.

That’s why leading European MedTech innovators such as OPED GmbH already rely on CertHub. As Stefan Kieslinger, Head of QM & RA at OPED, puts it:

“Seeing all our regulatory information in one model is a big step forward. CertHub lets us focus on data quality instead of formatting dozens of documents. With the analyzer we are always sure that all TechDoc data is correct and complete. Finally, the time we save and the ability to handle product families so easily makes a huge difference for our team.”

‍

Built by a Team with Rare Regulatory Credibility

‍

For us, the strongest reason to believe in CertHub is the team. Leon Kobinger and Nicolas Gehring combine regulatory depth, MedTech domain knowledge, and AI engineering at a level we rarely see and that is difficult to replicate.

Leon brings first hand experience from safety critical industries and has led certification processes himself as an auditor. Nicolas adds deep AI and platform expertise, having built large scale, production grade systems. Together, they pair regulatory rigor with modern AI infrastructure, exactly what is required to rethink compliance without lowering standards.

CertHub is not tackling an abstract problem. It is built by founders who understand the system from the inside and know where it breaks, giving them a unique ability to redesign it in a credible and scalable way.

Built in Munich, one of Europe’s leading MedTech ecosystems, and supported by institutions like UnternehmerTUM, CertHub benefits from a rare concentration of regulatory, technical, and entrepreneurial talent. This founder market fit and ecosystem strength underpin our conviction that CertHub can become the category defining compliance infrastructure for MedTech and beyond.

‍

Why We Invested in CertHub

‍

CertHub raised a €6.2 million oversubscribed Seed round led by Cusp Capital, with participation from D11Z, UnternehmerTUM, us, and a strong group of experienced business angels, including Axel Stepken, President and former CEO of TÜV SÜD.

At Calm/Storm, we invest in founders building category-defining healthcare infrastructure. CertHub is doing exactly that.

By becoming the shared operating system for compliance, CertHub has the potential to unlock innovation across the entire MedTech ecosystem. Faster certification means earlier patient access. Lower complexity enables more experimentation and innovation. Shared data and workflows create a more resilient regulatory system for the future.

Starting with MedTech, CertHub is laying the foundation for a broader vision: a shared compliance infrastructure connecting manufacturers and Notified Bodies.

We’re proud to support Leon, Nicolas, and the entire CertHub team on this journey. Regulatory complexity doesn’t have to slow healthcare innovation. With CertHub, it finally doesn’t.

‍