August 28, 2026
Some of the most important breakthroughs in healthcare don’t happen in research labs or operating rooms—they happen in the quiet, behind-the-scenes infrastructure that determines whether an innovation ever reaches a patient at all.
Today, medical technology is moving at lightspeed. AI diagnostics, novel medical devices, and digital therapeutics promise to transform patient care. Yet across Europe, too many life-saving innovations stall long before they ever touch a clinic. The roadblock isn't a lack of scientific ambition. It’s regulatory complexity.
Bringing a new medical device to market under Europe's MDR and IVDR regulations has become an operational nightmare. Teams have to wade through thousands of pages of technical documentation, navigate shifting requirements, and coordinate across dozens of stakeholders under immense time pressure.
The numbers speak for themselves:
This fragmented, manual system creates massive unpredictability. It delays crucial innovations and disproportionately hurts smaller, agile startups that simply don't have millions to spend on paperwork.
This is where CertHub comes in.
Instead of drowning in document-heavy, siloed spreadsheets, CertHub offers an AI-first compliance platform that turns regulatory approval into a continuous, clear, and collaborative process. The platform automates the heavy lifting, from generating Technical Documentation and Quality Management System files to streamlining audit prep.
This isn't just about helping founders skip paperwork; it helps the entire ecosystem. Notified Bodies (the regulators reviewing these files) get standardized data formats, higher-quality submissions, and far faster review cycles. By bridging the gap between manufacturers and auditors, CertHub is building the shared operating system MedTech desperately needs.
The impact is immediate: early customer data shows manufacturers reducing documentation time and costs by up to 60%, saving up to €2.4 million per certification cycle.
That’s why leading European innovators like OPED are already using it. As Stefan Kieslinger, Head of QM & RA at OPED, put 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... The time we save makes a huge difference for our team."
When tackling a heavily regulated, safety-critical industry, domain credibility is everything. You can’t just "move fast and break things" when human health is involved.
CertHub’s founders, Leon Kobinger and Nicolas Gehring, bring a rare combination of regulatory authority and deep AI engineering:
Together, they have created a platform with the exact regulatory rigor required to modernize compliance without ever lowering safety standards. Operating out of Munich, one of Europe’s premier MedTech ecosystems, backed by institutions like UnternehmerTUM, they have the perfect launching pad to scale.
CertHub recently raised a €6.2 million oversubscribed Seed round led by Cusp Capital, with participation from D11Z, UnternehmerTUM, us at Calm/Storm, and top-tier industry angels like Axel Stepken (former CEO of TÜV SÜD).
At Calm/Storm, we invest in super-driven teams building category-defining healthcare infrastructure. By solving the compliance bottleneck, CertHub isn't just saving companies money—they are helping life-saving innovations reach patients years faster.
We couldn't be prouder to back Leon, Nicolas, and the whole CertHub team as they build the future of MedTech infrastructure!
Are you a founder building infrastructure to transform healthcare? We’d love to connect! Reach out to the Calm/Storm team here or submit your pitch.
CertHub
AI-powered compliance management for medical devices
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Former Visiting Analyst
