eQMS

CertHub's Quality Management System (eQMS) is a digital platform built for medical device manufacturers that need to manage quality processes in line with ISO 13485, MDR, and IVDR requirements. It is designed to connect quality and product teams, centralise documentation, and automate recurring quality workflows such as SOPs, CAPAs, and audits.

The platform supports digital transformation of existing documentation — including legacy paper records, scanned files, PDFs, and spreadsheets — converting them into structured, searchable data within a single system. CertHub also offers related MedTech tools including Technical Documentation, Conformity Checker and Gap Analysis, QM Audit Checker, and UDI management with EUDAMED integration.

Workflow Automation

• Automated User Management: Processes are defined once, and tasks are automatically assigned to the appropriate roles and individuals.
• Simplified Documentation: Reports are pre-filled with existing product and company data to reduce manual documentation effort.
• Bridge Between Teams: Connects operations and QMS teams to maintain alignment on shared knowledge and processes.
• Interactive Process Modeler: Consolidates to-dos and forms in one place with smart reminders to keep tasks on track.
• Forms Manager: Supports sharing structured data in multiple formats and auto-generates forms directly from records.

Smart AI Assistant

• Comprehensive Search: Allows users to search across all data — including PDFs, scans, and Word documents — using a natural-language query in the search bar.
• Quick Overview: Provides instant summaries of retrieved information to reduce time spent reviewing documents.
• Direct Navigation: Takes users directly to the relevant location within the platform to continue working on specific tasks.
• Data Security: AI functionality is designed to keep user data secure throughout all interactions.

Version Control

• Maintains continuous version control for all document changes and product updates.
• Provides a traceable record of a product's development and maintenance history.
• Enables users to retrieve specific versions quickly to support audit readiness and demonstrate compliance.

Instant Digital Transformation

• All-in-One File Management: Manages and indexes all documents on a single platform, including legacy and scanned paper records.
• Hybrid File Upload: Accepts structured and unstructured files — including PDFs, Excel files, scans, and paper documents — and converts them into structured data.
• No Redundancy: Keeps all information synchronised in one location, eliminating the need for parallel updates across multiple systems.

Automated Approval Process

• Automated Notifications: Notifies the relevant colleagues automatically when their signature or approval is required.
• Digital E-Signature: Supports one-click signing of SOPs, work instructions, and records from any location.
• Secure and Compliant Signatures: Signatures are designed to meet compliance requirements for regulated quality processes.
• Role-Based Flexibility: Allows other users within the same role to sign documents during absences, preventing process delays.

CertHub is positioned as a MedTech-specific platform, with its eQMS sitting alongside tools for technical documentation, conformity checking, and EUDAMED/UDI management. The system is intended to support audit readiness and regulatory compliance under MDR and IVDR frameworks.