CertHub

CertHub GmbH, founded in 2024 in München, Germany, provides software solutions to streamline regulatory processes for the MedTech sector.CertHub specializes in providing AI-driven solutions tailored for the MedTech industry, focusing on Technical Documentation, Quality Management Systems (QMS), and Design Control. Their core offerings include a comprehensive framework for managing compliance with the EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR), enabling manufacturers to streamline their regulatory processes. The platform supports various risk classes, specifically Class I-III medical devices, in addition to specific adaptations for In-Vitro Diagnostics and Software as a Medical Device (SaMD). CertHub's solutions are designed to expedite regulatory submissions, enhance quality control, and reduce compliance-related workload, thus enabling faster time-to-market for new products.CertHub operates on a subscription-based revenue model, offering tiered plans that cater to varying needs within the MedTech industry. Clients enter into agreements to access their suite of AI-powered compliance solutions, which include tools for technical documentation, QMS management, and regulatory submissions. The transaction structure emphasizes direct B2B engagements, allowing manufacturers to subscribe for annual or monthly access to the platform. Pricing plans are structured to reflect the scale of the client's operations and specific needs, facilitating options for bulk licensing or single-user access depending on their requirements.2 million to expand its software platform into additional regions and enhance support for new regulatory standards. Specific markets targeted for expansion include North America and parts of Asia by the end of 2026, with a focus on increasing its footprint in these key regions.

1. Seed

   Dec 2, 2025

   Amount

   $7.2M

   Investors

   Locked