CertHub

What CertHub does

CertHub GmbH is a Munich-based software company that operates an AI-first Regulatory Information Management System (RIMS) for medical device manufacturers. The platform unifies electronic Technical Documentation (eTD) and an electronic Quality Management System (eQMS) under a single structured regulatory data model, covering EU MDR, EU IVDR, FDA 510(k), ISO 13485/14971, IEC 62304/62366, the EU AI Act, EUDAMED/UDI, and adjacent frameworks. Core modules include 1-Click Documentation generation, an AI Conformity & Gap Checker, a QM Audit Checker, a UDI and EUDAMED management module, and a Fast Track to CE Certification pathway. AI capabilities are delivered via EU-hosted agents (CertHub Brain) and through a Model Context Protocol server that connects CertHub workspaces to external assistants such as Claude, ChatGPT, Microsoft Copilot, and Cursor.

Name

CertHub

Legal name

CertHub GmbH

Website

https://certhub.de

Company type

Private

Founded year

2024

Operating status

Operating

Headcount range

11–50 employees

Short description

CertHub GmbH is a Munich-based AI-first Regulatory Information Management System that unifies electronic Technical Documentation and electronic Quality Management System for MedTech SMEs, IVD manufacturers, and SaMD developers operating under EU MDR, IVDR, FDA, and adjacent frameworks.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Compliance Software

NAICS

Software Publishers (5132)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Regulatory Information Management (RIM) & Submission Publishing Software (HLAGAJAL)

akta.pro secondary industries

Regulatory Operations & Publishing (eCTD, RIM, Submission Management) (HLAGAKAC), Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN), Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

Keywords

• Medical device compliance
• Regulatory information management
• Quality management software
• Technical documentation software
• MedTech regulatory AI

Headquarters

HQ city

München

HQ country

Germany

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Personnel, Technology or R&D, Marketing or Sales, Infrastructure, Operations

Revenue model

1. SaaS Subscription - Compliance Platform: AI-powered compliance platform for MedTech manufacturers. Likely subscription-based SaaS model with tiered pricing based on device count, features, and team size. Platform automates regulatory documentation, quality management, and audit preparation.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

CertHub sells an AI-first Regulatory Information Management System (RIMS) that unifies electronic Technical Documentation (eTD) and electronic Quality Management System (eQMS) for medical device manufacturers. The platform automates MDR/IVDR/FDA compliance documentation, conformity gap analysis, QM audit simulation, UDI/EUDAMED registration, and guided CE certification across three content domains: traditional medical devices (MediPureTech), in-vitro diagnostics (DxTech), and software as a medical device (SoftiTech). It is delivered as a SaaS platform with EU-hosted AI agents and integrations to developer tools such as Jira, Polarion, DOORS, and Dassault Systèmes.

Product overview

CertHub offers an AI-first Regulatory Information Management System (RIMS) combining electronic Technical Documentation (eTD) and electronic Quality Management System (eQMS) in a unified platform. The core CertHub Platform manages documentation, evaluations, and audits across international regulatory frameworks. The platform is built around three content domains: MediPureTech (traditional medical devices Class I-III), DxTech (in-vitro diagnostics under IVDR), and SoftiTech (software as medical device). Key modules include: 1-Click Documentation for automated TechDoc generation, AI Conformity Checker for gap analysis and audit simulation, QM Audit Checker for ISO 13485/MDR/FDA compliance verification, CertHub Brain (EU-hosted AI agents) and MCP Server (external AI integration) for AI-powered workflows, UDI & EUDAMED Management for automated regulatory registration, Fast Track to CE Certification for guided first-time compliance, and Digital QMS for workflow automation and document management. The platform serves MedTech SMEs and startups globally with support for EU MDR/IVDR, FDA 510(k), ANVISA, UK MDR, Health Canada, TGA, and other jurisdictions.

Differentiator

Problem solved

Functional benefit

Brands

• TED-MeD: Trusted Engineering Design for Medical Devices - a collaborative research project between CertHub, Modelwise GmbH, and FAU to help MedTech SMEs streamline development and compliance with AI-driven safety tools.

Products and services

• CertHub Platform (RIMS) AI-first Regulatory Information Management System (RIMS) unifying electronic Technical Documentation (eTD) and electronic Quality Management System (eQMS) for medical device manufacturers. Manages documentation, evaluations, and audits across EU MDR, EU IVDR, FDA 510(k), and other international frameworks, with three content domains: MediPureTech (traditional medical devices), DxTech (IVD), and SoftiTech (SaMD).
• 1-Click Documentation (eTD + eQMS) Module that generates full TechDoc packages with a single click, including Risk Files, Clinical Evaluations, and supporting documentation in PDF, Markdown, HTML, and ZIP formats. Imports legacy Word/Excel files via AI extraction and propagates live updates across documents.
• AI Conformity Checker AI-powered gap analysis and compliance checking tool that performs portfolio-wide gap analysis, tracks completeness for submissions, simulates QMS audits, and validates TechDoc submissions against Notified Body expectations. Multi-standard coverage including ISO 13485, ISO 14971, IEC 62366, and EN ISO 15189.
• QM Audit Checker AI-powered QMS audit simulation tool that simulates real QMS audits against ISO 13485, MDR Annex IX, and FDA 21 CFR Part 820 requirements. Four-stage process covers scope/standards definition, QMS document upload, automated audit simulation, and audit-ready report generation with severity-ranked findings and corrective actions plans.
• CertHub Brain EU-hosted AI agent system running inside the CertHub platform with direct access to workspace compliance data without data leaving the EU. Designed for regulated workloads requiring EU data residency, BSI C5 customers, and MDR-bound teams handling clinical data.
• CertHub MCP Server Model Context Protocol server integration connecting the CertHub workspace to external AI assistants (Claude, ChatGPT, Microsoft Copilot, Cursor) with OAuth authentication. Provides structured access to compliance data, control implementations, evidence, gap assessments, and supplier lists from within existing AI tools.
• UDI & EUDAMED Management Automated UDI management and EUDAMED XML generation module. AI extracts UDI data from PDFs, Excel, Word, and scanned forms with confidence scores and generates schema-validated EUDAMED XML without requiring XML coding. Manages UDI-DI per variant, hierarchical packaging levels, Basic UDI-DI registration, and UDI-PI data.
• Fast Track to CE Certification Guided onboarding and certification pathway for first-time CE marking. The Certification Assistant configures the knowledge model, preloads correct templates, and sets up submission structure based on device classification, intended use, software components, risk levels, and target users. Covers Class I-III devices including hardware, IVD, and SaMD products.
• Digital Quality Management System (eQMS) Electronic QMS connecting Quality Management and Product teams with workflow automation, smart AI assistant for searching across documents, version control with full audit trail, instant digital transformation of paper/PDF/Excel files, and automated approval process with e-signatures.
• Technical Documentation Module Digital technical documentation system for MDR/IVDR/FDA submissions with single source of truth for product data, Smart Editor, standardized submission-ready templates aligned with Notified Body expectations, multi-jurisdictional data reuse, version control, and Smart AI search.

Quantifiable outcome

• 60% faster regulatory submissions for traditional medical devices
• +10 more outcomes

Named customers1 record

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration8 records

AI capability8 records

Feature9 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Modelwise GmbHcoreStrategic or Co-development PartnerCollaborative research partner in TED-MeD project. Modelwise specializes in automated functional safety analysis for reducing risks and accelerating MedTech development.
• FAU (Friedrich-Alexander University Erlangen-Nürnberg)coreStrategic or Co-development PartnerAcademic research partner in TED-MeD project. FAU/SPARC, led by Prof. Dr. Franziska Mathis-Ullrich, contributes expertise in AI, robotics, and translational biomedical engineering.
• Technical University of Munich (TUM)coreStrategic or Co-development PartnerUniversity affiliation and research partner. Prof. Dr. Oliver Hayden serves as TUM Chair of Biomedical Electronics and Academic Director MedTech, Venture Labs Healthcare. Company developed in Munich ecosystem.
• Prof. Dr. Oliver Hayden (TUM)minorStrategic or Co-development PartnerAcademic advisor. Head of Translatum & TUM Chair of Biomedical Electronics, Academic Director MedTech, Venture Labs Healthcare.
• Axel StepkenminorOthersFormer CEO & President of TÜV SÜD. Senior advisor providing deep expertise in certification and Notified Body operations.
• Erik VollebregtminorOthersExpert lawyer for EU MedTech Regulations providing legal and regulatory advisory expertise.

Scale indicators6 records

Recent moves6 records

Expansion highlights7 records

Broad incumbents

• Sparta Systems (Honeywell): Provider of TrackWise QMS used by many MedTech and pharma manufacturers for quality, regulatory and compliance workflows. Functions as an established incumbent competitor to CertHub's QMS module in regulated manufacturing.
• MasterControl: Long-standing enterprise QMS, document control and compliance suite serving MedTech, pharma and other regulated industries. Competes with CertHub in the broader MedTech compliance category but at larger enterprise scale with broader portfolio.
• ArisGlobal: Life sciences technology provider offering regulatory information management, safety and clinical solutions. Overlaps with CertHub on RIM and submission management but serves broader life sciences portfolio including pharma.
• Veeva Vault (Veeva Systems): Industry-standard regulated content and data management platform used across life sciences for submissions, QMS and clinical operations. Operates as a broad incumbent whose RIM and Vault QMS capabilities overlap with CertHub's positioning.

Direct peers

• Qualio: eQMS platform built for life sciences and MedTech companies, providing document control, training and audit management. Directly competes with CertHub's digital QMS module in the same SME MedTech customer segment.
• Greenlight Guru: Cloud-based eQMS and quality management platform purpose-built for medical device companies, covering design controls, risk management and submissions. Directly comparable to CertHub in targeting MedTech SMEs with a SaaS compliance product.
• Dot Compliance: AI-powered QMS and compliance platform for life sciences companies, offering automated quality management and document workflows. Closely comparable to CertHub's AI-first approach to MedTech QMS and document automation.
• ComplianceQuest: Cloud-native QMS and EH&S platform built natively on Salesforce with specific MedTech and life sciences capabilities. Comparable to CertHub in providing digital QMS and document workflows to regulated manufacturers.

Emerging players

• AssurX: Quality management and regulatory compliance software with strength in medical device and life sciences QMS workflows. Comparable to CertHub's eQMS offering for regulated manufacturers seeking digital alternatives.
• Polaris Compliance Solutions: Compliance software vendor focused on regulated industries including medical devices. Comparable emerging player in the same regulatory documentation and submission management niche as CertHub.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/certhub-ai

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds1 record

Investors5 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CertHub