1-Click Documentation

1-Click Documentation is a module within CertHub, an electronic Quality Management System (eQMS) and electronic Technical Documentation (eTD) platform built for the MedTech industry. It is designed for regulatory and quality management teams — regardless of company size — who are responsible for creating and maintaining MDR/IVDR-compliant documentation, particularly those currently working in Word, Excel, or legacy eQMS and document management tools.

The platform addresses the problem of manual, repetitive document creation that is difficult to keep consistent across product variants and regulatory submissions. CertHub's approach centres on a structured Knowledge Model that stores product and regulatory data centrally, then generates and updates documentation automatically from that single source of truth.

Core Capabilities

• Legacy Document Transfer: CertHub uses AI to extract knowledge from existing Word and Excel files and converts that information into its structured Knowledge Model, allowing teams to migrate legacy documentation without starting from scratch.
• Knowledge Model and Template Selection: Once product information is entered into the Knowledge Model, CertHub automatically selects the appropriate regulatory templates — covering areas such as risk management, Instructions for Use (IFUs), and clinical evaluation — based on built-in regulatory logic.
• Live Update Propagation: A single change to a data point — such as a risk entry or intended purpose — is automatically reflected across all connected documents and submissions. Updated versions are generated immediately, and every file remains traceable throughout the process.
• One-Click Document Generation: With a single action, CertHub assembles the complete Technical Documentation package in multiple output formats including PDF, Markdown, HTML, and ZIP, with each paragraph traceable back to its source data.

Supported Document and Compliance Areas

• Technical Documentation (eTD) for MDR and IVDR submissions
• Quality Management System (QMS) documentation
• Conformity Checker and Gap Analysis
• QM Audit Checker
• UDI management and EUDAMED integration
• Design Control documentation

Regulatory Compliance Maturity Assessment

• CertHub provides an online self-assessment tool that scores an organisation's readiness to adopt digital compliance and regulatory technology.
• The assessment covers dimensions including openness to digital tools, IT infrastructure readiness, data structure and accessibility, standardisation of compliance processes, existing digital system usage, integration with enterprise systems such as ERP, CRM, and PLM, degree of automation in compliance activities, and systematic review of regulatory processes.
• Completed assessments can be followed up with a consultation with a CertHub expert.

CertHub is positioned as a combined eQMS and eTD solution supporting compliance with MDR, IVDR, and additional regulatory frameworks. The platform targets MedTech manufacturers managing both new device development and large volumes of legacy files or multiple product variants.