CertHub closes €6.2M Seed Round led by Cusp Capital to accelerate MedTech compliance

CertHub GmbH · Munich, Germany

CertHub, the AI-first compliance platform for medical device manufacturers and Notified Bodies, today announced the closing of a €6.2 million seed round led by Cusp Capital. The round includes D11Z (Dieter Schwarz), Calm/Storm, UnternehmerTUM Funding for Innovators, and nine business angels including Axel Stepken (former CEO of TÜV SÜD, Chairman of TÜV SÜD Foundation). CertHub will use the funding to scale across European manufacturers and embed its technology inside Notified Bodies.

2025

Press Release

CertHub launches NB Auditor Co-Pilot, bridging the gap between manufacturers and Notified Bodies

CertHub GmbH · Munich, Germany

CertHub becomes the first company to serve both sides of the MedTech certification process on a single AI platform. European Notified Bodies are already using the NB Auditor Co-Pilot in production, saving up to 176 hours per conformity assessment.

Tech.eu

January 7, 2026

CertHub raises €6.2M to tackle MedTech's compliance bottleneck

Munich-based startup addresses the regulatory burden in European MedTech with AI-first compliance automation.

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Munich Startup

January 2026

CertHub receives €6.2 million euros

Coverage of CertHub's seed round and its plans to scale AI-powered compliance across European medical device manufacturers.

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Handelsblatt

2026

CertHub erschließt 6,2 Millionen Euro frisches Kapital

Deutschlands führende Wirtschaftszeitung berichtet über CertHubs Seed-Runde und die Digitalisierung der MedTech-Compliance.

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Handelsblatt

2026

eQMS-Software für die Medizintechnik von CertHub

Handelsblatt stellt CertHubs spezialisierte eQMS-Lösung für elektronisches Qualitätsmanagement in der Medizintechnik vor.

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Leon Kobinger, CertHub Founder on Calm/Storm

Calm/Storm VC

2025

Leon Kobinger, CertHub Founder Profile

Europe's most active healthcare investor profiles CertHub's CEO and the company's vision for eliminating compliance bottlenecks.

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Our mission is to remove the regulatory bottlenecks that hold back medical innovation. Ultimately, this means life-changing medical technologies reach patients sooner.

Leon Kobinger

Co-Founder & CEO, CertHub

What convinced us most is the team. CEO Leon Kobinger brings first-hand experience from safety-critical industries and has led certification processes himself as an auditor.

Dr. Carolin Althoff

General Partner, Cusp Capital

CertHub passes TÜV Süd Audits and saves 60% time to get there.

Dr. Mario Roser

Managing Director & CTO, Elixion Medical GmbH

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Fact Sheet

Key stats, company profile, market data, and leadership overview.

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Product Screenshots

High-res images of the CertHub platform, dashboards, and key features.

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Leadership Photos

Professional headshots of co-founders Leon Kobinger and Nicolas Gehring.

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Boilerplate · English

CertHub is a next-generation AI-first compliance platform for MedTech manufacturers and Notified Bodies. The system streamlines the entire regulatory process from Technical Documentation and Quality Management System documentation to automated audit checks, reducing time-to-certification by 60%, lowering costs, and increasing predictability for medical device approvals. After successfully passing TÜV audits with its software, CertHub is the only company serving both manufacturers and Notified Bodies, and is now scaling across European manufacturers while embedding its technology inside Notified Bodies themselves. Founded by Leon Kobinger and Nicolas Gehring, CertHub is backed by Cusp Capital, D11Z (Dieter Schwarz), Calm/Storm, UnternehmerTUM, and prominent business angels including Axel Stepken (former CEO of TÜV SÜD, Chairman of TÜV SÜD Foundation).

Boilerplate · Deutsch

CertHub ist eine KI-gestützte Compliance-Plattform der nächsten Generation für MedTech-Hersteller und Benannte Stellen. Das System optimiert den gesamten Zulassungsprozess von der Technischen Dokumentation und QMS-Dokumentation bis hin zu automatisierten Prüfungen und reduziert die Zeit bis zur Zertifizierung um 60%, senkt Kosten und erhöht die Planbarkeit für Medizinprodukte-Zulassungen. Nach erfolgreichem Bestehen von TÜV-Audits mit seiner Software und als einziges Unternehmen, das sowohl Hersteller als auch Benannte Stellen zu seinen Kunden zählt, skaliert CertHub nun europaweit bei Herstellern und integriert seine Technologie direkt in Benannten Stellen.

Why cover CertHub?

The European medical device market is experiencing its biggest regulatory shift in decades. The MDR transition has increased compliance costs by 40-70% according to MedTech Europe, with Notified Body certification timelines regularly exceeding 13-18 months. CertHub is at the center of this transformation, offering a story that spans AI innovation, healthcare access, and regulatory policy.

Whether you cover health tech, enterprise SaaS, European startups, or AI · whether through articles, podcasts, video, or live events · there's a compelling angle here.

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40-70% Higher MDR compliance costs (MedTech Europe)

13-18 mo Notified Body certification timelines

90% Of MDR costs are personnel-driven

Suggested story angles

Here are a few angles we think resonate with different audiences. We're happy to tailor briefings to your beat.

AI & Enterprise SaaS

How CertHub applies AI to a domain where accuracy is literally a matter of life and death · and what that means for regulated-industry AI adoption.

Healthcare Access

The hidden bottleneck: how slow medical device approvals delay life-saving innovations, and why CertHub's 60% time reduction matters for patients.

European Startup Ecosystem

A Munich-based B2B deep-tech startup raises €6.2M from top European investors. What CertHub reveals about the state of European healthtech funding.

Regulatory & Policy

MDR transition, Notified Body capacity crisis, and the emerging role of AI in regulatory workflows. A policy deep-dive.

Notified Bodies & the Two-Sided Platform

CertHub is the first company to serve both MedTech manufacturers and Notified Bodies on a single AI platform. How connecting both sides of the certification table creates a new category in compliance software.

The Auditor Bottleneck

European Notified Bodies are drowning in assessment backlogs while manufacturers wait months for certification. How CertHub's NB Auditor Co-Pilot saves up to 176 hours per conformity assessment and triples auditor throughput.

Leon Kobinger

Co-Founder & CEO

Medical engineer with backgrounds in mathematics and computer science from TUM. Former systems engineer at Airbus, where he worked on safety-critical systems for next-generation aircraft. UnternehmerTUM Manage and More fellow.

Nicolas Gehring

Co-Founder & CTO

Deep engineering expertise from building large-scale cloud systems. Previously at Avelios Medical, where he gained first-hand experience with healthcare IT and regulatory requirements. Drives CertHub's technical architecture and AI capabilities.

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BayStartUP Winner

Bavarian Startup Accelerator

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BMBF Funded

Federal Ministry of Education & Research

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UnternehmerTUM

Europe's Leading Innovation Center

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TUM Research

200+ Pages Published

Get in Touch

For interviews, media inquiries, creator partnerships, or additional information about CertHub.

press@certhub.de

certhub.de • LinkedIn • Munich, Germany

Everything you need
to cover CertHub

Press Releases

CertHub closes €6.2M Seed Round led by Cusp Capital to accelerate MedTech compliance

CertHub launches NB Auditor Co-Pilot, bridging the gap between manufacturers and Notified Bodies

Media Coverage