CertHub

CertHub is an AI-first software platform providing electronic Technical Documentation (eTD), electronic Quality Management System (eQMS), and Design Control capabilities for the MedTech industry. It is designed to help medical device manufacturers — with a focus on SMEs — prepare regulatory submissions and maintain compliance with EU MDR, EU IVDR, ISO 13485, and a range of other international standards, without extensive manual paperwork.

The platform supports medical device products across risk classes I, IIa, IIb, and III, covering traditional medical devices, in-vitro diagnostics (IVD), and Software as a Medical Device (SaMD). CertHub is backed by a network of over 150 MedTech industry experts, advisors, and supporters.

Core Features

• Fast Track to Certification and QMS ISO 13485: An AI Certification Assistant helps prepare QMS and technical documentation for submission within a few weeks, tailored to specific medical devices.
• 1-Click Documentation (eTD and eQMS): The fully validated eTD and eQMS modules make documentation audit-ready with 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, MDR Annex IX, and FDA requirements, and generates a corrective actions plan. Operates as a plug-and-play AI agent requiring no integration.
• Conformity and Gap Checker: Assesses documentation readiness from initial stages through to submission, performing gap analysis and pre-audit checks to verify 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 QMS and technical documentation for Class I–III devices, including design controls, risk management, clinical evaluation, and regulatory submissions. Includes ISO 13485 QMS templates, EU MDR Technical Documentation, Risk Management (ISO 14971), Usability Engineering (IEC 62366), and EUDAMED/UDI registration. Reported to deliver 60% faster regulatory submissions and 40% reduction in regulatory review cycles.
• DxTech (In-Vitro Diagnostics — IVDR): Provides specialised content for IVD manufacturers, including analytical and clinical performance studies, quality control, and IVDR-specific requirements. Covers IVDR compliance templates, performance evaluation, quality control procedures, notified body submissions, and EUDAMED/UDI registration. Reported to achieve a 50% reduction in IVDR transition costs.
• SoftiTech (Software as a Medical Device — SaMD): Offers a framework for SaMD development covering software lifecycle processes, cybersecurity, AI/ML validation, and digital health regulations. Includes IEC 62304 software lifecycle, EU AI Act compliance, cybersecurity (IEC 81001-5-1), digital health pathways, and EUDAMED/UDI registration. Reported to support 70% faster SaMD development cycles and AI Act readiness.

Regulatory Frameworks and Jurisdictions Covered

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

Reported Efficiency Metrics

• Reduced time and cost for initial certification
• Reduction in repetitive documentation work
• More efficient regulatory processes overall

CertHub is targeted at MedTech companies of all sizes, with a particular focus on SMEs. The platform is described as already in use and having passed audits. It includes built-in content for all covered regulatory frameworks at no additional cost, and the AI agents for audit checking and gap analysis operate without requiring external system integrations.