Shypd.aiThe largest open index of AI toolsCertHub is an AI-powered compliance tool that streamlines technical documentation, QMS, and design control for MedTech manufacturers. It helps accelerate MDR/IVDR compliance and certification processes.
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CertHub offers AI-powered software solutions specifically designed for Technical Documentation (eTD), Quality Management Systems (eQMS), and Design Control within the MedTech industry. It aims to simplify MDR/IVDR compliance, enabling manufacturers to innovate faster by reducing paperwork and streamlining regulatory processes. Key features include 1-Click Documentation for audit-ready eTD and eQMS, a QM Audit Checker that simulates audits against ISO 13485/MDR/FDA requirements, and a Conformity & Gap Checker for pre-submission analysis. CertHub supports various medical device use cases, including traditional medical devices, in-vitro diagnostics, and Software as Medical Device (SaMD), covering regulations like EU MDR, IVDR, FDA 510(k), ISO 13485, and IEC 62304. The platform is designed to be user-friendly, helping companies achieve certification and QMS readiness in weeks.
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Likely Not Free
Not publicly disclosed. Check certhub.de for current pricing.
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