A Munich startup just landed a significant financial boost to solve one of the healthcare industry’s biggest headaches. CertHub has successfully raised €6.2 million in a fresh funding round to use artificial intelligence to slash the time it takes to get medical devices approved for public use. With strict regulations currently tightening their grip across Europe, this new technology promises to cut years off the waiting game and get life saving tools to patients much faster.
The company secured this investment in just two months. This speed highlights how desperate the market is for a solution to the regulatory jam. The funding round was led by Cusp Capital. It also saw participation from existing investors and industry veterans who understand the pain of compliance firsthand.
Solving the Multi Billion Dollar Compliance Crisis
The medical technology sector in Europe is currently facing a massive hurdle. Manufacturers are struggling to keep up with new and rigorous standards known as the Medical Device Regulation or MDR. These rules are necessary for patient safety. However, they have created a massive backlog of paperwork and bureaucratic red tape.
Recent data paints a worrying picture for the industry. Roughly 70 percent of manufacturers report that they are struggling significantly with these regulatory burdens. It is not just a headache. It is an expensive problem. Implementing these new requirements is estimated to cost the industry over €12 billion.
Obtaining market approval for a single medical device today takes an average of 5 years and costs companies more than €4 million in compliance labor.
This delay acts as a structural bottleneck. It slows down innovation across the entire sector. Small companies often run out of cash before they can get their products to market. Even large corporations are forced to pull older products from the market because recertifying them costs too much money.
This situation creates a dangerous gap for patients. Innovative devices that could detect cancer earlier or manage diabetes better are stuck in limbo. They sit in piles of paperwork instead of being in hospitals where they belong. CertHub aims to break this dam using modern software.
AI automation software interface for medical device regulatory compliance documents
How AI Cuts Documentation Costs by 60 Percent
CertHub is tackling this inefficiency with an AI first approach. Their platform does not just digitize paper documents. It automates the entire creation of complex regulatory files. This includes technical documentation generation and quality management system reports.
The traditional method involves teams of humans manually typing out thousands of pages of reports. This is slow and prone to human error. CertHub replaces these fragmented workflows with structured regulatory models.
The results from early customers are promising. Manufacturers using the platform have saved up to 60 percent on documentation time and costs.
“Our mission is to remove the regulatory bottlenecks that hold back medical innovation.”
Leon Kobinger, Co-founder and CEO of CertHub
This efficiency translates to real money. The startup estimates a potential saving of €2.4 million per certification cycle for a device. That is money companies can reinvest into research and development.
The platform also helps the Notified Bodies. These are the organizations responsible for auditing and approving the devices. They benefit from receiving higher quality documentation in standardized formats. This allows them to review files faster and clear the backlog of pending approvals.
Key Benefits of the Platform
- Automated Workflows: Replaces manual data entry with intelligent automation.
- Audit Preparation: Streamlines the process of getting ready for external inspections.
- Standardized Formats: Ensures all documents meet the strict requirements of regulators.
- Cost Reduction: Lowers the barrier to entry for smaller innovators.
Industry Veterans and Top Investors Back the Vision
The rapid success of this funding round is largely due to the team behind the company. Investors were not just buying into software. They were buying into the founders.
CEO Leon Kobinger brings a unique perspective to the table. He has firsthand experience in safety critical industries like aviation. Aviation has long been the gold standard for safety and compliance. Kobinger has also led certification processes himself as an auditor. He knows exactly where the pain points are because he has lived through them.
CTO Nicolas Gehring complements this with strong engineering expertise. Together, they have built a system that balances modern speed with the rigor required for medical safety.
Dr. Carolin Althoff from Cusp Capital noted that this combination gives CertHub rare credibility to modernize digital compliance without compromising on safety.
The list of investors adds further weight to their mission. The round included participation from D11Z, Calm/Storm, and UnternehmerTUM. Perhaps most notably, nine prominent business angels joined the round. This includes Axel Stepken. He is the President and former CEO of TÜV SÜD. His involvement is a massive vote of confidence from the very top of the certification industry.
The Investment Roster
| Investor Type | Name/Firm | Significance |
|---|---|---|
| Lead Investor | Cusp Capital | Leading VC focused on digital infrastructure. |
| Participants | D11Z, Calm/Storm, UnternehmerTUM | Strong network in European tech ecosystem. |
| Key Angel | Axel Stepken | Former CEO of TÜV SÜD, bringing deep industry trust. |
Expansion Plans and the Future of Digital Certification
CertHub plans to use this fresh capital to scale its operations rapidly. Their immediate goal is to expand the platform across Europe. The European market is currently the epicenter of the compliance crisis due to the MDR transition.
However, the ambition goes beyond Europe. The company plans to develop “jurisdiction packs” for other major markets. This includes the United States and Brazil. These packs will tailor the AI to specific local regulations. This will allow manufacturers to sell their products globally with less friction.
The long term vision is even bigger. CertHub wants to build the first shared compliance infrastructure. This would connect manufacturers directly with Notified Bodies in a seamless digital environment.
By doing this, they aim to create the world’s most valuable dataset on certification outcomes. This data could eventually enable predictive compliance. Imagine a system that can tell you if your device will be approved before you even submit the paperwork. This would fundamentally change how medical devices are built and sold.
Ultimately, this means life changing medical technologies reach patients sooner.
The healthcare industry is often slow to adopt new digital tools. But the pressure of rising costs and strict regulations is forcing a change. CertHub is positioning itself as the essential infrastructure for this new era. They are turning compliance from a barrier into a streamlined process.
In a world where technology moves fast but regulation moves slow, CertHub is building the bridge between the two. This funding round proves that investors believe they are the ones to cross it.
The journey has just begun for the Munich team. But with €6.2 million in the bank and a clear roadmap, they are ready to fix a broken system. The winners in this story are not just the investors or the founders. The real winners will be the patients who get access to better healthcare technology when they need it most.
