CertHub, a fast-growing MedTech compliance and regulatory automation startup, has secured €6.2 million in seed funding, completing the round in under two months. The investment was led by Cusp Capital, with participation from D11Z Ventures, Calm/Storm, UnternehmerTUM, and several high-profile angel investors, including Axel Stepken, former President and CEO of TÜV SÜD.
Mounting Regulatory Pressure in MedTech
The raise comes at a time when MedTech manufacturers across Europe face unprecedented regulatory constraints. New requirements under frameworks such as the EU’s Medical Device Regulation (MDR) have significantly increased the administrative burden for companies, with many reporting that compliance processes have become one of their greatest operational challenges.
On average, bringing a medical device to market now requires around five years and more than €4 million in compliance-related labour. Industry-wide, adapting to evolving regulations is estimated to cost companies billions in additional documentation, auditing, and procedural efforts. These delays not only strain manufacturers but also slow the arrival of life-changing medical innovations to patients.
AI-Driven Platform Tackling Compliance Bottlenecks
CertHub aims to solve these structural inefficiencies with its AI-first regulatory automation platform, designed to streamline and accelerate certification workflows. The system automates major regulatory processes, including:
- Generation of technical documentation
- Quality Management System (QMS) documentation
- Audit preparation and submission workflows
- Structured regulatory models and standardized templates
By replacing fragmented manual processes with intelligent, model-based automation, CertHub significantly reduces administrative workload. Early adopters report up to 60% savings in time and cost associated with documentation, equating to roughly €2.4 million saved per certification cycle.
The platform also improves the experience of Notified Bodies, which review and approve medical device submissions. Standardised documentation, clearer data structures, and reduced variance across submissions enable faster, more predictable assessments.
Investor Confidence Rooted in Deep Domain Expertise
Cusp Capital and other investors emphasised the strength of CertHub’s founding team as a key driver of the funding round. CEO Leon Kobinger brings extensive experience from safety-critical industries, including aviation, and has previously worked on both sides of certification workflows as an engineer and auditor. CTO Nicolas Gehring adds strong technical leadership and platform engineering expertise.
According to investors, this combination of regulatory understanding and high-level engineering capability gives CertHub a rare advantage in modernising compliance processes without compromising regulatory depth or rigour.
Scaling Across Europe and Beyond
With the new funding, CertHub plans to expand its platform and support infrastructure across Europe, deepen integrations with Notified Bodies, and enhance predictive capabilities within its AI models. A significant portion of the investment will also go toward developing market-specific regulatory packs for major international regions, including the United States and Brazil, enabling global MedTech manufacturers to manage multi-jurisdictional compliance through a single system.
Toward a Shared Compliance Infrastructure
Looking ahead, CertHub aims to build the first shared regulatory infrastructure connecting manufacturers, auditors, and notified bodies. By aggregating certification-related data and outcomes (while maintaining regulatory integrity), the company envisions enabling predictive compliance, more consistent decision-making, and accelerated market approvals across the industry.
Ultimately, CertHub’s long-term mission is to remove the certification bottlenecks that currently slow medical innovation, helping companies bring life-changing technologies to patients sooner while maintaining the highest safety and quality standards.
