eQMS for Medical Devices
ISO 13485, MDR & IVDR Ready

Connect your Quality Management and Product Teams together and be always on the same page

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Workflow Automation

Automated User Management: Define your process once—tasks auto-assign to the right roles and people.

Simplified Documentation: Reports are pre-filled with product and company data to make documentation fast and effortless.

Bridge Between Teams: Connect your operations and QMS teams to ensure alignment on shared knowledge.

Interactive Process Modeler: All to-dos and forms in one place—with smart reminders.

Forms Manager: Share structured data in any format and auto-generate forms from records.

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Smart AI Assistant

Comprehensive Search: Find exactly what you need across all data—just ask in the search bar.

Quick Overview: Instantly see clear summaries of the information you need.

State of Art Data Security: Use AI confidently—your data stays secure at every step.

Direct Navigation: Go straight to the right place to continue working on detailed tasks.

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Versioning

Version Control: Maintain continuous version control for all changes and updates.

Proof of Evolution: Clearly demonstrate your product’s journey through development and maintenance.

Always be Audit-Ready: Easily jump to the versions you need and demonstrate compliance during audits.

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Instant Digital Transformation

All-in-One File Management: Manage and search all documents including legacy documents—even scanned papers—on a single platform.

Hybrid File Upload: Upload any structured/unstructured file—CertHub transforms PDFs, Excels, scans, and papers into structured data.

No Redundancy: Skip parallel updates—CertHub keeps everything synced in one place.

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Automated Approval Process

Automated Notifications: CertHub automatically notifies colleagues when it's their turn to sign.

Digital E-Signature: Sign SOPs, instructions, and records with one click—anytime, anywhere.

Secure & Compliant: Ensure secure, compliant signatures for all processes.

Role-Based Flexibility: Keep processes moving—others in the role can sign during absences.

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CertHub offers AI-fueled software solutions for Technical Documentation, QMS and Design Control - tailored to the MedTech industry.

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