TL;DR: CertHub’s €6.2M Funding Revolutionizes Medtech Compliance
CertHub raised €6.2 million in January 2026 to disrupt medtech compliance with AI-powered automation, solving extensive regulatory hurdles faced by startups. Its solutions streamline documentation, global conformity assessments, and annual audits, cutting compliance time by up to 60%. With plans to expand across Europe, the U.S., and Brazil, CertHub is redefining how startups approach regulation-heavy industries.
• Automates complex regulatory workflows for faster approvals
• Supports global documentation and audit integration
• Leads innovation to enhance patient care access
This milestone highlights the importance of scalable tech solutions for entrepreneurs in regulated industries. Learn key strategies on securing funding and scaling in similar sectors at Best Startup Events in the Netherlands. Follow CertHub’s journey, as they reshape medtech compliance globally.
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In January 2026, CertHub achieved a milestone by successfully raising €6.2 million to address one of the most pressing concerns in the medtech industry: streamlining regulatory compliance processes. This investment is a bold signal that the healthcare compliance sector is ripe for a disruptive reimagining. For startups like CertHub, this capital injection is not just about expansion but a step forward in leveraging technology to expedite life-saving innovations. Let’s explore why this funding is a potential game-changer for the medtech world and what it means for founders navigating regulated industries.
Why Is Medtech Compliance Such a Challenge?
Medtech startups face significant hurdles in complying with the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). According to industry data, 70% of medtech manufacturers struggle with compliance, leading to costly delays and setbacks. Approvals for new medical devices can take an average of five years and cost over €4 million in labor for compliance documentation. This isn’t just a financial bottleneck, it directly impacts innovation and patient care. For startups without the resources of larger corporations, navigating these frameworks often feels like an insurmountable mountain.
Why Founders Need Smarter Solutions
From my perspective as a European entrepreneur, medtech founders need more than just grit to survive, they need tools that simplify the complex web of compliance. Without these technologies, small teams spend precious time on paperwork instead of innovation. Compliance isn’t a one-time activity; it’s continuous, iterative, and frequently misunderstood by new inventors. Automating workflows and reducing manual effort is no longer a “nice-to-have” but essential if companies want to get their products into hospitals efficiently.
What Is CertHub Doing Differently?
CertHub has positioned itself as a pioneer by automating core regulatory workflows. Their AI-powered compliance platform offers medtech companies a central digital environment to manage technical documentation, conformity assessments, and audit preparations in one place. The team, led by CEO Leon Kobinger and CTO Nicolas Gehring, leverages decades of combined experience in safety-critical industries to build a credible, scalable solution for regulatory pain points.
- Reduction in documentation time: up to 60% savings for manufacturers.
- Integration with Notified Bodies for faster audit reviews.
- Jurisdiction-specific packs for global compliance (starting with the U.S. and Brazil).
- Long-term goal: building the world’s most valuable compliance data repository for predictive analytics.
These features aren’t theoretical, they’re already delivering value to its customers. By creating a “compliance backbone” for medtech, CertHub ensures that life-saving solutions reach patients quicker and more efficiently.
What Makes CertHub’s Team Stand Out?
CertHub’s success is partly driven by the unique backgrounds of its founders. Leon Kobinger brings insight from aviation’s hyper-regulated space, while Nicolas Gehring’s expertise in engineering ensures the platform is both technologically robust and medically precise. With a clear mission and the brains to back it, CertHub reassures potential customers and investors that it’s not just another SaaS experiment, but an essential pillar of medtech’s digital evolution.
How Will This €6.2 Million Be Used?
CertHub plans to focus the fresh funding on scaling across Europe while expanding integrations with more Notified Bodies. They’ll also venture into two complex but lucrative markets: the U.S. and Brazil. This level of ambition requires significant investment not just in technology but in regulatory expertise and customer education. Their long-term vision to unify medtech compliance under one shared infrastructure could drastically improve global patient outcomes while making compliance far less burdensome.
What This Means for Entrepreneurs in Regulated Sectors
If you’re a founder in a regulated industry, CertHub’s fundraising highlights two important lessons. First, the capital markets are hungry for scalable solutions addressing complex but essential problems. And second, having deep domain expertise, whether as a founder or within your team, is critical when tackling industry pain points. Regulators and customers don’t just want faster processes; they want certainty that these solutions meet their exacting standards.
What Should You Watch For Next?
CertHub is only one player in a growing “compliance tech” ecosystem, but its success could set a precedent for SaaS startups solving similar problems in high-stakes industries. Investors will likely watch how quickly the platform can onboard manufacturers and deliver tangible outcomes, such as shortened time-to-market and cost savings. Startups in other regulated spaces should take note: disruptive solutions don’t always have to bypass regulations, they can embrace and enhance them. That’s where opportunities for real impact lie.
Why You Should Care
If faster approvals for life-saving technologies impact your business or health, this is a space worth following. Consumers and companies alike should root for startups like CertHub, as they deepen access to innovation while maintaining the high bar of safety patients deserve.
Final Thoughts
CertHub’s €6.2M seed round isn’t just another line in the medtech news cycle; it’s a movement toward making one of the world’s most bureaucratically complex systems manageable. For aspiring founders and medtech veterans alike, the takeaway is clear: the intersection of AI and compliance is fertile ground for creating both value and impact. When you automate inefficiencies in high-stakes sectors, you do more than build a scalable business, you help shape the future.
Want to learn more about CertHub’s journey? Head over to CertHub’s official page, or keep an eye on their progress across Europe and beyond. Their story is a compelling case for how smart funding and focused execution can redefine an industry.
FAQ on CertHub's Funding and Medtech Compliance
How will CertHub’s €6.2M funding impact medtech compliance?
CertHub’s recent funding will be instrumental in alleviating bottlenecks faced by medtech companies. By expanding its AI-powered compliance platform across Europe and entering new markets like the U.S. and Brazil, CertHub aims to accelerate regulatory processes. The funding supports their mission to ensure faster medical device approvals, thereby improving innovation and patient care. Explore CertHub’s innovations
Why do medtech companies struggle with regulatory compliance?
Medtech companies often face hurdles due to the complexity of standards like MDR and IVDR. Certification timelines can span up to five years, costing over €4 million in compliance efforts. Small startups struggle the most, lacking resources to navigate extensive regulatory demands. Read about medtech acceleration in the Netherlands
What makes CertHub’s platform standout?
CertHub’s AI-first platform streamlines regulatory workflows by automating documentation, quality management systems, and audit preparations. It offers jurisdiction-specific solutions and collaborates with Notified Bodies to expedite compliance reviews. Proven results include up to 60% time and cost reductions in compliance processes, enabling quicker market entry for medical innovations. Learn more about CertHub’s approach
How does CertHub differ from competitors in compliance tech?
CertHub specializes in medtech compliance, leveraging AI to improve accuracy and efficiency. Their long-term vision includes creating the largest compliance data repository for predictive analytics, a feature unique in this space. Discover success stories of AI medtech startups in Pittsburgh
What industries could learn from CertHub’s model?
Sectors with high regulatory demands, such as aviation and pharmaceuticals, could adopt similar AI-driven compliance systems to optimize processes. CertHub’s success showcases how technology can eliminate bottlenecks in diverse industries. Explore lessons from other regulated sectors
What role does CertHub’s leadership play in its innovation?
CertHub’s leadership brings unparalleled expertise. CEO Leon Kobinger draws from decades in aviation, a hyper-regulated sector, while CTO Nicolas Gehring contributes robust engineering and medical precision. Their combined experience ensures credibility and technological excellence. Check out female entrepreneurs thriving in regulated sectors
How will CertHub use its funding to expand globally?
The €6.2M funding will be used to scale across Europe, integrate with additional Notified Bodies, and customize solutions for international markets. CertHub plans to venture into the U.S. and Brazil while investing in customer education about compliance tools. Read about startup expansion strategies across Sweden
What are the main benefits of CertHub’s platform for manufacturers?
CertHub offers faster documentation and audit preparation, significant manual effort reductions, and jurisdiction-specific compliance packs. Its automated tools give manufacturers a competitive edge by shortening time-to-market and saving costs. Explore insights on Gibraltar’s innovative compliance startups
What trends does CertHub’s success reflect in the startup ecosystem?
CertHub is part of the growing trend of AI-powered tools solving complex regulatory problems. Investors and founders are increasingly drawn to scalable solutions that enhance efficiency without compromising on compliance. This is shaping the future of startups in regulated sectors. Master startup trends in regulated industries
Why should medtech innovators follow CertHub’s progress?
CertHub’s success signifies a shift in resolving compliance bottlenecks through AI. Faster approvals for life-saving technologies benefit both the industry and patient outcomes. Innovators can learn valuable insights about scaling efficiently within regulatory frameworks. Uncover pivotal resources for medtech founders in Europe
About the Author
Violetta Bonenkamp, also known as MeanCEO, is an experienced startup founder with an impressive educational background including an MBA and four other higher education degrees. She has over 20 years of work experience across multiple countries, including 5 years as a solopreneur and serial entrepreneur. Throughout her startup experience she has applied for multiple startup grants at the EU level, in the Netherlands and Malta, and her startups received quite a few of those. She’s been living, studying and working in many countries around the globe and her extensive multicultural experience has influenced her immensely.
Violetta is a true multiple specialist who has built expertise in Linguistics, Education, Business Management, Blockchain, Entrepreneurship, Intellectual Property, Game Design, AI, SEO, Digital Marketing, cyber security and zero code automations. Her extensive educational journey includes a Master of Arts in Linguistics and Education, an Advanced Master in Linguistics from Belgium (2006-2007), an MBA from Blekinge Institute of Technology in Sweden (2006-2008), and an Erasmus Mundus joint program European Master of Higher Education from universities in Norway, Finland, and Portugal (2009).
She is the founder of Fe/male Switch, a startup game that encourages women to enter STEM fields, and also leads CADChain, and multiple other projects like the Directory of 1,000 Startup Cities with a proprietary MeanCEO Index that ranks cities for female entrepreneurs. Violetta created the “gamepreneurship” methodology, which forms the scientific basis of her startup game. She also builds a lot of SEO tools for startups. Her achievements include being named one of the top 100 women in Europe by EU Startups in 2022 and being nominated for Impact Person of the year at the Dutch Blockchain Week. She is an author with Sifted and a speaker at different Universities. Recently she published a book on Startup Idea Validation the right way: from zero to first customers and beyond, launched a Directory of 1,500+ websites for startups to list themselves in order to gain traction and build backlinks and is building MELA AI to help local restaurants in Malta get more visibility online.
For the past several years Violetta has been living between the Netherlands and Malta, while also regularly traveling to different destinations around the globe, usually due to her entrepreneurial activities. This has led her to start writing about different locations and amenities from the point of view of an entrepreneur. Here’s her recent article about the best hotels in Italy to work from.
