Recensioni e Dettagli del Prodotto CertHub

CertHub is an AI-first Quality Management System (QMS) and Technical Documentation platform built for medical device manufacturers operating under EU MDR (2017/745), EU IVDR (2017/746), and ISO 13485. We help MedTech teams achieve CE marking faster, maintain audit-ready documentation, and manage regulatory compliance without the overhead of traditional enterprise QMS tools. Built for the complexity of modern medical device regulation Regulatory compliance for medical devices has never been more demanding. MDR and IVDR introduced stricter requirements for clinical evidence, post-market surveillance, and technical documentation. Requirements that generic document management tools and spreadsheet-based systems simply were not designed to handle. CertHub was purpose-built to close that gap. Our platform structures your entire compliance workflow around the actual requirements of MDR Annex II and III, ISO 14971 risk management, and ISO 13485 quality management. Traceability between requirements, design controls, risk controls, and verification evidence is built in from day one, not retrofitted after an audit finding. What regulatory teams use CertHub for Medical device manufacturers use CertHub to create and maintain Technical Documentation, build and manage SOPs and Work Instructions, run structured risk management processes aligned with ISO 14971, and generate audit-ready compliance records. Our AI layer accelerates document drafting, identifies regulatory gaps, and keeps content aligned with the latest applicable standards, reducing the time from development to CE marking submission by weeks. Who CertHub is designed for CertHub is the right fit for MedTech startups pursuing their first CE mark, mid-sized manufacturers scaling their product portfolio, and regulatory affairs consultants managing compliance across multiple clients. If your team is navigating the MDR/IVDR transition, preparing for a Notified Body audit, or building out your EUDAMED-ready documentation infrastructure, CertHub removes the complexity and gives your team a clear, structured path forward. Why customers choose CertHub Unlike horizontal QMS platforms that require months of configuration to fit a medical device context, CertHub is regulatory-native. Every workflow, template, and AI suggestion is grounded in MDR, IVDR, and harmonized standard requirements. Teams typically go from onboarding to their first compliant Technical Documentation in days, not months. Headquartered in Germany, CertHub serves medical device companies across the DACH region and internationally, with customers ranging from early-stage startups to established manufacturers preparing for global market expansion.Sonnet 4.6