eTD Features
Modular regulatory capabilities powered by one structured data model
From core modules to concrete features used in daily regulatory work.
Powerful automation built-in
Beyond data management - eTD automates the tedious work of regulatory documentation.
meddevo Document Writer
Generate documents from templates or write intelligent documents from scratch. Documents automatically redline and update themselves when underlying data changes.
- Generate documents from templates using validated eTD data
- Write intelligent documents from scratch
- Automatic redlining when underlying data changes
- Self-updating documents that stay current with your data model
Documents are no longer static outputs.
They are living views of your regulatory data.
meddevo Inspector
Continuously verify completeness across your technical documentation. Know what is missing before anyone asks.
- Checks for errors and missing data in the eTD data model
- Monitors all documents for up-to-dateness
- Verifies document signatures and approval status
- Checks submissions for update gaps
Instead of reacting during audits, you stay proactively compliant.
Output Format
meddevo Folder Preview
Never manage documents in folders manually again. Based on configurable templates, meddevo gives you a live preview of your current TDs in your desired formats. For example:
One data source. Multiple output formats.
Always audit-ready, always up to date.
Building blocks of eTD
Each module addresses specific regulatory challenges while sharing the same structured data foundation.
eTD Data Model
Multilingual TD content management
The core of eTD: a structured data model specifically designed for medical device technical documentation. Manage all regulatory content as interconnected data instead of isolated documents.
Key Capabilities
- Configurable data collections for products, components, and materials
- Multilingual content fields with translation workflows
- Full traceability across all data relationships
- Live impact analysis before any changes
- Version control with complete audit history
Problems Solved
medtech DMS
Document management system
Purpose-built document management for regulatory teams. Generate, version, and approve documents from validated data with full CFR 21 Part 11 compliance.
Key Capabilities
- Automated document generation from eTD data
- Digital approval workflows
- Microsoft Office integration
- Folder automation and organization
- Document redlining
Problems Solved
eStandards
Standards & MDCG monitoring
Stay ahead of regulatory changes with automated standards monitoring. Track applicable standards, receive change notifications, and manage compliance evidence.
Key Capabilities
- Automated tracking of standards
- MDCG guidance document monitoring
- Implementation process
- Change notifications
Problems Solved
eSubmission
Regulatory submissions
Streamline your regulatory submission process. Compile submission dossiers from validated TD data with automatic structuring for notified body requirements.
Key Capabilities
- Automated dossier compilation with zero redundancy
- Notified body format presets
- Submission status tracking
- Registration Management
- Audit-ready submission archives
Problems Solved
UDI Management
Device identification
Comprehensive UDI data management.
Key Capabilities
- UDI-DI and Basic UDI Data Management
- Data model according to EUDAMED
- Reuse of UDI data across documents and TDs
Problems Solved
GSPR Manager
Safety requirements
Systematic management of General Safety and Performance Requirements. Map requirements to evidence, track compliance status, and generate GSPR checklists.
Key Capabilities
- GSPR requirement mapping
- Evidence linking and traceability
- Automated checklist generation
- Gap identification and tracking
Problems Solved
Risk Management
Supporting ISO 14971 compliance
Syncing eTD data with risk management plans and reports.
Key Capabilities
- Automated chapters from TD
- Shared content between other processes
- Creation of plan and report
Problems Solved
Clinical Evaluation
CER documentation
Manage clinical evaluation projects and generate CERs supported by structured data.
Key Capabilities
- Automated chapters from TD
- Shared content between other processes
- Literature management
- CEP/CER generation and updates
Problems Solved
Complete feature list
Detailed capabilities for advanced buyers and auditors.
| Feature | Description | CategoryCat. |
|---|---|---|
| Audit Trail | 21 CFR Part 11 compliant change tracking with full version history and user attribution | Compliance |
| Workflow Management | Configurable multi-step review and approval workflows with role-based permissions | Compliance |
| Two-Factor Authentication | SMS-based 2FA for enhanced account security and unauthorized access prevention | Security |
| Single Sign-On (SSO) | Enterprise SSO via WorkOS with SAML 2.0 and OpenID Connect support | Security |
| Content Management | Centralized product portfolio management with EU-MDR Annex II & III compliant data model | Data Management |
| Document Management | Full DMS with automated document generation, monitoring, and version control | Document Generation |
| Collections (Databases) | Pre-configured data collections with cross-references to eliminate redundancy | Data Management |
| Data Connections | Visualize and navigate incoming, outgoing, and indirect data relationships | Data Management |
Real-world impact
How eTD transforms regulatory workflows for medical device teams.
< 1 hour
Standard update across all TDs
When a standard is updated, propagate changes across all affected technical documentation in under one hour instead of weeks.
90%
Reduced document maintenance
Automated document generation from validated data eliminates manual copy-paste and formatting work.
Real-time
Compliance visibility
Always know your compliance status across products, standards, and submissions with live dashboards.
Ready to see eTD in action?
Schedule a personalized demo to see how eTD can transform your regulatory documentation workflow.