Removing Regulatory Bottlenecks in MedTech
AI-First Compliance Platform for Medical Devices
CertHub is a Munich-based B2B SaaS company that revolutionizes medical device certification through AI-driven automation. Our platform streamlines technical documentation, quality management systems, and audit preparation, helping manufacturers navigate complex regulatory requirements with unprecedented speed and efficiency. By replacing fragmented manual workflows with intelligent automation, we enable medical device companies to achieve certification up to 60% faster, saving up to €2.4 million per certification cycle.
Our mission is to remove the regulatory bottlenecks that hold back medical innovation.
Building the Future of Medical Device Compliance
Long-term, CertHub aims to build the first shared compliance infrastructure connecting manufacturers and Notified Bodies, creating the world’s most valuable dataset on certification outcomes. This will enable predictive compliance and data-driven product approvals, ensuring that life-changing medical technologies reach patients sooner. Our vision is making certification faster, more predictable, and accessible for manufacturers across Europe and beyond.
1-Click Documentation eTD + eQMS
Regulatory teams still manage MDR and IVDR documentation in Word, Excel, or outdated systems. This leads to repetitive manual work, inconsistent documents, and high error risk.
CertHub replaces document-based work with a structured, AI-powered compliance system. Existing files are transformed into a connected knowledge model. A single change updates all related documents automatically. Complete technical documentation packages can be generated in one click, fully traceable and submission ready.
The result: faster submissions, consistent documentation across all products, and no more copy-paste work.
Fast Track to Certification
CertHub’s Certification Assistant guides medical device companies from first idea to regulatory submission. Regulatory expertise is built directly into the software, leading teams step-by-step through a fully digital process tailored to their specific device.
Companies simply describe their product. CertHub configures the correct documentation structure, selects the required templates, and adapts all content to the chosen regulatory pathway. An integrated regulatory AI supports interactive content creation, while the complete technical documentation package is generated automatically and ready for submission.
The results: significantly less regulatory expertise required in-house, major cost savings for initial certification, and a reduction of timelines from months to weeks.
CertHub supports traditional medical devices (MDR), in-vitro diagnostics (IVDR), and Software as a Medical Device (SaMD), combining QMS, risk management, performance evaluation, and software lifecycle requirements in one unified solution.
Conformity Checker AI & Gap Analysis
MedTech SMEs and startups often face delays and rising costs because documentation gaps are discovered too late, during audits or submission reviews.
CertHub supports teams from early gap analysis to final submission. The platform identifies missing content, tracks completeness in real time, and runs intelligent pre-audit and submission checks to ensure documentation is accurate, defensible, and aligned with MDR, IVDR, and global requirements.
Within minutes, companies gain full transparency about the quality and status of their QMS and technical documentation for specific jurisdictions such as the EU or FDA. Audit readiness can be assessed at any time.
The result: fewer surprises, faster approvals, and clear visibility into compliance maturity, long before a notified body or authority review.
The Hidden Costs of MDR & IVDR Compliance: How to be Ready?
Explore the hidden costs of MDR and IVDR compliance in the MedTech industry. Learn how certification, maintenance, re-certification, and operational challenges impact businesses, and discover strategies to stay ahead of rising costs.
Investment Focus Areas
- IT Infrastructure
- Sales Intelligence
- eCommerce
- Security