# CertHub

> AI-first compliance platform for MedTech manufacturers. CertHub automates electronic Technical Documentation (eTD), Quality Management Systems (eQMS), and Design Control for EU MDR, IVDR, FDA 510(k), and ISO 13485.

## About

CertHub GmbH builds software that helps medical device manufacturers create, manage, and submit regulatory documentation. The platform uses AI to automate compliance workflows — from gap analysis and conformity checking to 1-click document generation. Over 150 MedTech companies use CertHub to get CE-marked faster.

## Core Products

- [1-Click eTD Documentation](https://www.certhub.de/en/documentation-with-the-push-of-a-button): Generate MDR/IVDR-compliant electronic Technical Documentation in hours. AI-powered document generation with full traceability.
- [AI Conformity Checker & Gap Analysis](https://www.certhub.de/en/ai-conformity-checker): Instant MDR/IVDR conformity assessment. Identifies compliance gaps and generates remediation plans automatically.
- [QM Audit Checker](https://www.certhub.de/en/qm-audit-checker): Simulates real QMS audits against ISO 13485, MDR Annex IX, and FDA requirements. Finds non-conformities before the auditor does.
- [eQMS](https://www.certhub.de/en/qms): Electronic Quality Management System for MedTech, ISO 13485 and MDR compliant.
- [RIMS](https://www.certhub.de/en/rims): Regulatory Information Management System. Automate EU MDR, IVDR, and FDA 510(k) submissions from a single European data model.
- [UDI & EUDAMED Management](https://www.certhub.de/en/eudamed-udi-management): Automate UDI data extraction, XML validation, and EUDAMED submission in minutes.

## Use Cases

- [Fast-Track CE Certification](https://www.certhub.de/en/fast-track-CE): Get CE-marked weeks faster with AI-powered certification workflows.
- [Pre-Certification](https://www.certhub.de/en/pre-certification): Guide MedTech startups from first documentation to CE submission.
- [Multi-Product Compliance](https://www.certhub.de/en/multi-product-compliance): Scale compliance across multiple product lines and device portfolios.

## Resources

- [Blog](https://www.certhub.de/en/blog-articles): Articles on MDR, IVDR, ISO 13485, BSI C5, UDI, and MedTech compliance topics.
- [Resource Hub](https://www.certhub.de/en/resources-hub): Webinars, guides, and compliance tools.
- [Press](https://www.certhub.de/en/press): Press kit and media resources.

## Company

- Founded: 2023
- HQ: Germany
- Website: https://www.certhub.de
- Demo: https://www.certhub.de/en/demo
- LinkedIn: https://www.linkedin.com/company/certhub-ai

## Regulations Covered

EU MDR 2017/745, EU IVDR 2017/746, ISO 13485:2016, ISO 14971, IEC 62304, FDA 21 CFR Part 820 (QMSR), FDA 510(k), BSI C5, EUDAMED, UDI-DI/UDI-PI

## Blog Posts

- [FDA QMSR: What Changes for ISO 13485-Certified Manufacturers Entering the US Market](https://www.certhub.de/en/blog-articles/fda-qmsr-iso-13485-certified-us-market): ISO 13485 certification doesn't cover QMSR. FDA's updated QMS regulation adds two sections your notified body never audits: §820.35 (records control) and §820.45 (labeling). Here's where the gaps are and what to fix before an inspector finds them.
- [FDA QMSR: Was sich für ISO 13485-zertifizierte Hersteller beim Markteintritt in die USA ändert](https://www.certhub.de/de/blogartikel/fda-qmsr-aenderungen-iso-13485-hersteller): Ihr ISO 13485-Zertifikat gilt nicht für QMSR. Erfahren Sie, wo die zwei FDA-spezifischen Lücken liegen und was Sie vor dem US-Markteintritt anpassen müssen.
- [MDR Clinical Investigations: The Pathway Decision Guide (Plus Every Deadline You Need to Track)](https://www.certhub.de/en/blog-articles/mdr-clinical-investigation-pathway-guide): Article 62, 74, or 82? A practical walk-through of MDCG 2021-6 Rev. 1, the decision tree, the documentation, and the timelines that decide whether your clinical investigation lands in regulatory good standing or stalls before first patient in.
- [BSI C5:2026 Audit Readiness: A Practical Guide for Cloud Service Providers](https://www.certhub.de/en/blog-articles/bsi-c5-2026-audit-readiness-guide-cloud-providers): What the new Cloud Computing Compliance Criteria Catalogue means for your next audit, and how to prepare before the June 2027 deadline.
- [BSI C5:2026 Audit-Readiness: Ein praktischer Leitfaden fuer Cloud-Diensteanbieter](https://www.certhub.de/de/blogartikel/bsi-c5-2026-audit-leitfaden): Was der neue Cloud Computing Compliance Criteria Catalogue fuer Ihre naechste Pruefung bedeutet, und wie Sie sich vor der Frist im Juni 2027 vorbereiten.**
- [The Hidden Costs of MDR & IVDR Compliance: How to be Ready? ](https://www.certhub.de/en/blog-articles/the-hidden-costs-of-mdr-and-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 are impacting businesses, and discover strategies to stay ahead of rising costs.
- [Die versteckten Kosten der MDR- und IVDR-Konformität: Wie Sie sich wirkungsvoll vorbereiten](https://www.certhub.de/de/blogartikel/versteckte-kosten-mdr-ivdr-konformitaet-vorbereitung): Erfahren Sie mehr über die versteckten Kosten der MDR- und IVDR-Konformität. Wie Zertifizierung, Wartung und Re-Zertifizierung MedTech-Unternehmen belasten – und welche Strategien wirklich helfen.
- [From Jira to Submission: How CertHub Connects Jira to MedTech Technical Documentation](https://www.certhub.de/en/blog-articles/from-jira-to-submission-closing-the-dev-to-regulatory-gap): CertHub's Jira integration syncs developer requirements directly into MDR, IVDR, and IEC 62304 technical documentation, closing the gap between engineering and regulatory teams without manual copy-paste.
- [Von Jira zur Einreichung: Wie CertHub Jira mit der MedTech-Technischen Dokumentation verbindet](https://www.certhub.de/de/blogartikel/von-jira-zur-einreichung-die-luecke-zwischen-entwicklung-und-zulassung): Wie CertHub Jira-Anforderungen live in die Technische Dokumentation überträgt und die Lücke zwischen Entwicklung und Regulatory schließt — für MDR, IVDR, IEC 62304 und weltweite Einreichungen aus einem gemeinsamen Datenmodell.
- [MDR/IVDR 2.0: What the EU Commission's December 2025 Reform Proposal Means for MedTech SMEs](https://www.certhub.de/en/blog-articles/mdr-ivdr-2-0-eu-commission-reform-proposal-medtech-smes): The EU Commission published COM(2025) 1023 to reform MDR/IVDR. Six key changes for SMEs: Rule 11 software reclassification, no more 5-year certificate cap, standardized NB timelines, simpler equivalence, orphan/breakthrough pathways, and AI Act simplification.
- [MDR/IVDR 2.0: Was der Reformvorschlag der EU-Kommission vom Dezember 2025 für MedTech-KMU bedeutet](https://www.certhub.de/de/blogartikel/mdr-ivdr-2-0-reformvorschlag-eu-kommission-medtech-kmu): Die EU-Kommission veröffentlichte COM(2025) 1023 zur Reform von MDR/IVDR. Sechs zentrale Änderungen für KMU: Regel 11 Neuklassifizierung, Wegfall der 5-Jahres-Zertifikatsfrist, standardisierte Fristen für Benannte Stellen, einfachere Äquivalenz, Orphan-/Breakthrough-Wege, KI-Vereinfachung.
- [UDI Requirements Under EU MDR 2017/745: A Complete Decision Tree for Medical Device Manufacturers](https://www.certhub.de/en/blog-articles/udi-requirements-eu-mdr-decision-tree-medical-device-manufacturers): A step-by-step guide to assigning UDI identifiers, registering in EUDAMED, and staying compliant with Regulation (EU) 2017/745.
- [UDI-Anforderungen gemäß EU-MDR 2017/745: Der vollständige Entscheidungsbaum für Medizinproduktehersteller](https://www.certhub.de/de/blogartikel/udi-requirements-eu-mdr-decision-tree-medical-device-manufacturers): Eine Schritt-für-Schritt-Anleitung zur Vergabe von UDI-Kennzeichnungen, zur Registrierung in EUDAMED und zur Einhaltung der Verordnung (EU) 2017/745.
- [TED-MeD Launches: Empowering MedTech SMEs With AI-Driven Safety & Compliance](https://www.certhub.de/en/blog-articles/ted-me-d-launches-empowering-med-tech-sm-es-with-ai-driven-safety-and-compliance): CertHub, Modelwise, and FAU have launched TED-MeD, a research project funded by €956,832 to help MedTech SMEs streamline development and compliance. With an AI assistant and process model, the project aims to speed up certification and bring safer devices to market faster.
- [TED-MeD startet: KI-gestützte Sicherheit und Konformität für MedTech-KMU](https://www.certhub.de/de/blogartikel/ted-med-startet-ki-gestuetzte-sicherheit-konformitaet-medtech-kmu): CertHub, Modelwise und die FAU starten TED-MeD: ein mit 956.832 € gefördertes Forschungsprojekt, das kleine und mittlere Medizintechnikunternehmen bei der Entwicklung und regulatorischen Konformität unterstützt.
- [AI for MDR Compliance: From Manual Firefighting to Structured Audit Readiness](https://www.certhub.de/en/blog-articles/ai-for-mdr-compliance): For many small and mid-sized medical device manufacturers, MDR compliance looks manageable on paper. The regulation is structured. The annexes are defined. The expectations of Notified Bodies are documented.
- [Two Paths to Agentic Compliance: Run Agents Inside CertHub or Connect Your Own](https://www.certhub.de/en/blog-articles/certhub-brain-and-mcp-server): Compliance teams want to work with agents in the tools they already use. We've made that possible two ways, one keeps your data inside the EU, the other lets you bring ChatGPT, Copilot, or Claude to your workspace in about a minute. Here's how to choose.
- [Webinar - Fast Track to CE Mark: From Idea to Submission](https://www.certhub.de/en/resource-webinar/webinar-from-concept-to-cc-mark): Built for MedTech founders and regulatory teams navigating EU MDR & IVDR for the first time. See how CertHub structures the CE Mark process, and leave with a concrete action plan for your own device.