eTD

CertHub's Technical Documentation (eTD) is a digital documentation platform designed for MedTech companies that need to produce, manage, and maintain regulatory technical documentation. It targets quality and regulatory affairs teams looking to reduce manual effort in creating audit-ready submissions, with the platform claiming up to 60% time savings by allowing product and company data to be entered once and reused across multiple documents.

The platform is part of CertHub's broader suite of MedTech software solutions, which also covers QMS, Design Control, Conformity Checking, UDI management, and EUDAMED. eTD specifically addresses the documentation workflows required for regulatory submissions across multiple jurisdictions including EU MDR, FDA 510(k), Anvisa, and the PMD Act.

Single Source of Truth

• Centralises structured product and company data in one location to eliminate inconsistencies and redundant data entry.
• Allows information to be reused automatically across documents, removing the need to copy and paste content manually.
• Provides quality and regulatory teams with access to find, edit, and manage data with transparency and traceability.
• Supports pre-submission checks to verify that the correct documents and content are in place before submission.

Smart Editor

• Generates documents by connecting product data and QMS content to Notified Body-specific templates.
• Links to the Single Source of Truth so that content can be managed and reused across multiple documents.
• Automatically transforms verification records into formatted lists, reducing manual formatting work for regulatory teams.
• Supports images, tables, and custom styles, with the ability to export documents to PDF in a preferred format.

Submission-Ready Templates

• Automatically fills document templates when product and company information is entered.
• Offers pre-built document structures aligned with Notified Body expectations, with the option to define custom structures and include external test reports.
• Supports both standardised templates and user-defined templates for different product types.
• Generates document sections based on product data to reduce manual authoring effort.

Multi-Jurisdictional Regulatory Support

• Provides tailored templates for EU MDR, FDA 510(k), Anvisa, PMD Act, and other regulatory frameworks.
• Allows existing product data to be reused across different jurisdictions, simplifying multi-market regulatory maintenance.
• Enables adaptation of existing application content to new regulatory requirements with minimal additional effort.

Versioning and Revision Control

• Tracks product and process changes throughout the development lifecycle.
• Maintains continuous version control, allowing users to access and revert to previous document versions.
• Records the evolution of a product over development and maintenance cycles to support audit demonstrations.
• Provides detailed version histories to facilitate compliance reviews during audits.

Smart AI Assistant

• Accepts natural language queries through a search wizard to retrieve information quickly.
• Scans company data, product data, and external PDFs such as clinical evaluations to return precise search results.
• Provides concise summaries of relevant information in response to queries.
• Navigates users directly to the relevant section of the platform to continue detailed work.

CertHub eTD is positioned as a cloud-based platform tailored to the MedTech industry. It integrates with other CertHub modules including QMS, Conformity Checker, Gap Analysis, QM Audit Checker, and UDI management, supporting end-to-end regulatory and quality workflows within a single environment.