CertHub is driven by a solution-focused team with +50 years of combined regulated experience and proven track record in building robust software technologies for 20 million users.
We are the perfect fit for the regulated industry: European-first with hosting on German servers, development in Germany, and guided by experienced regulatory experts.
Superpower: Guiding MedTech companies from vision to practical success. Background: 13+ years in Regulatory Affairs & Quality Management Contact for: IVD & SaMD Expert, Clinical Research, Road to Success
Superpower: Finding the best solutions and help customers to act, the proof of the pudding is in the eating! Background: 11 yrs hands-on experience in developing safety-critical AI products and bringing them to the market. QMB & i. Auditor (TÜV) Contact for: EU MDR Hardware & SaMD, Audits, AI Usage in MedTech
Superpower: Nothing is impossible. Background: Built compliant scalable cloud software and infrastructure for 20M+ users Contact for: Cybersecurity in MedTech, EU AI Act, Software Validation (e.g. CSV)
Superpower: Guiding customers to success fast — simple, effective and fun! Background: Engineer with a heart for people, bridging customer success and product for long-lasting adoption and value. Contact for: Road to Success, Digitalisation Strategies, Customer onboarding & training
Superpower: Scaling MedTech growth with regulatory expertise and strategic partnerships. Background: 15+ years in Regulatory Affairs, Quality Management, and Digital Transformation; built teams and partnerships at Johner Institute; worked with Fresenius, Philips, B.Braun, and more. Contact for: International Market Expansion, Regulatory Strategy, Quality & Compliance Journeys.
We collaborate closely with our partners and customers to transform the internal quality and regulatory processes to exceed expectations. We question the status quo and improve our software platform rapidly and continuously. We are aware of the regulatory responsibility that our work and our software carries, and we act in a forward-looking manner in accordance with ethical, legal, and privacy requirements to stay for decades.
Our mission is to empower medical device manufacturers to bring innovative medical products and cutting-edge technologies to market faster, enabling the best possible patient care. We address one of the industry’s most persistent and difficult challenges: navigating complex and time-consuming regulatory processes. By automating tedious compliance work through our structured data approach, we unlock AI capabilities and workflow automation, making companies audit-ready at the push of a button. This not only ensures 100% compliance but also accelerates certification by years and delivers substantial cost savings.
Be part of the team.
CEO and Co-Founder Kumovis (3D Systems)
Head of Translatum & TUM Chair of Biomedical Electronics Academic Director MedTech, Venture Labs Healthcare
Regulatory Affairs Manager HP Medizintechnik GmbH & MD at HP Med Consulting GmbH
Founder & CEO Ocumeda
Managing Director & Founder Evoleen
Head of QM & RA FRIZ Biochem GmbH
Executive Director Advanced Technology | Global Research & Development bei Karl Storz SE & Co. KG
Freelance Auditor for multiple Notified Bodies, Medical Device Expert
CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.
© CertHub 2025
