CertHub

CertHub is a Munich-based software company that develops AI-powered compliance tools for the medical device industry. Its platform covers electronic Technical Documentation (eTD), electronic Quality Management Systems (eQMS), and Design Control, and is aimed primarily at small and medium-sized MedTech manufacturers working with traditional medical devices, in-vitro diagnostics (IVD), and Software as a Medical Device (SaMD). The platform is built and hosted in Germany, co-funded by the EU, and is used by more than 150 MedTech industry experts across device risk classes I, IIa, IIb, and III.

CertHub's stated goal is to reduce the time and cost associated with regulatory submissions and quality management by automating documentation workflows through a structured data approach. The platform is designed to make companies audit-ready without requiring deep regulatory knowledge from every user, and it covers a broad range of international standards and regulatory frameworks within a single subscription.

Core Products and Modules

• Fast Track to Certification and QMS ISO 13485: An AI Certification Assistant that helps prepare QMS and technical documentation for regulatory submission within a few weeks, tailored to the specific medical device in question.
• 1-Click Documentation (eTD and eQMS): A fully validated electronic Technical Documentation and Quality Management System module that generates audit-ready documentation in a single action, supporting both new documentation and migration of legacy files.
• QM Audit Checker: Simulates a real QMS audit and management review, flags non-conformities against ISO 13485, EU MDR Annex IX, and FDA requirements, and produces a corrective actions plan. Operates as a plug-and-play AI agent requiring no integration.
• Conformity and Gap Checker: Assesses documentation readiness from initial drafting through to submission, performing gap analysis and pre-audit checks to verify that each entry is defensible. Also operates as a plug-and-play AI agent with no integration required.
• UDI Management and EUDAMED: Supports EUDAMED registration and UDI management without requiring a separate XML solution or ERP integration.

Content Domains

• MediPureTech (Traditional Medical Devices / MDR): Covers comprehensive QMS and technical documentation for Class I–III medical devices, including design controls, risk management, clinical evaluation, and regulatory submissions. Relevant standards and content include ISO 13485 QMS templates, EU MDR Technical Documentation, ISO 14971 risk management, IEC 62366 usability engineering, and EUDAMED/UDI registration. Reported outcomes include 60% faster regulatory submissions and a 40% reduction in regulatory review cycles.
• DxTech (In-Vitro Diagnostics / IVDR): Provides specialised content for IVD manufacturers, covering analytical and clinical performance studies, quality control, and IVDR-specific requirements. Includes IVDR compliance templates, performance evaluation documentation, quality control procedures, and notified body submission support. Reported outcomes include a 50% reduction in IVDR transition costs and faster time-to-market for new diagnostics.
• SoftiTech (Software as a Medical Device / SaMD): Offers a complete framework for SaMD development, including software lifecycle processes, cybersecurity, AI/ML validation, and digital health regulations. Covers IEC 62304 software lifecycle, EU AI Act compliance, IEC 81001-5-1 cybersecurity, and digital health pathways. Reported outcomes include 70% faster SaMD development cycles and readiness for the EU AI Act.

Regulatory and Standards Coverage

• EU MDR and EU IVDR
• EUDAMED and UDI registration
• EU AI Act and EU Cyber Resilience Act
• FDA 510(k)
• ISO 13485, ISO 14971, IEC 62304
• GDPR
• IMDRF and MDCG guidelines

Deployment and Infrastructure

• Hosted on German servers with development carried out in Germany.
• Co-funded by the European Union and positioned as a European-first solution.
• Plug-and-play AI agents for audit checking and gap analysis require no external integrations.
• The platform has been used in real audits by existing customers.

Team and Advisory Network

• The founding and leadership team brings over 50 years of combined experience in regulated industries, including regulatory affairs, quality management, safety-critical AI development, and cloud software engineering for large-scale deployments.
• Key team members include Leon Kobinger (Managing Director, QMB and internal auditor certified by TÜV, 11 years in safety-critical AI), Nicolas Gehring (Managing Director, background in compliant cloud infrastructure for 20 million-plus users), Dr. Sebastian Grömminger (Head of Regulatory and Quality, 13-plus years in regulatory affairs and quality management, IVD and SaMD specialist), Julia Sommer (Head of Product), and Luca Salvatore (Head of Growth, 15-plus years in regulatory affairs and quality management, previously at Johner Institute, with experience working alongside Fresenius, Philips, and B.Braun).
• The advisory and expert network includes academics and industry professionals from institutions and companies such as TU Munich, Kumovis (3D Systems), HP Medizintechnik, Karl Storz, and FRIZ Biochem, as well as freelance notified body auditors.

CertHub serves MedTech companies seeking to reduce the administrative and regulatory burden of certification and ongoing quality management, with a particular focus on SMEs navigating EU MDR, IVDR, and international frameworks. The platform is available in English and German.