Tools for RA & QA 

Developed with the manufacturer in mind

Content based Technical Documentation

Full configurable multi language Content Management allows you focusing on Data, not Documents. Out of the box EU-MDR ready and MDSAP countries enabled regulatory frameworks.

Single Source of Truth, Audit Trail, 21 CFR Part 11 Compliant
Data Overview with Export / Import
MDR ready according ANNEX I, II, III
Worldwide management e.g.: MDR, IVDR, PPE, ANVISA, FDA
Comment functions and Bulk Changes on complete Portfolio

Intelligent Documents and Automation

Integrated Document Writer let you write rich and intelligent documents that will keep themself up to date. Reusing redundant free data out of your eTD pushing your data integrity to new hights. Start from scratch, use templates or create your own. Set your documents on autopilot.

Integrated Document Writer
Intelligent eTD Data connection
Automated Updates
Document Templates

Automated Folder Structures and Submissions

Never manage Dossiers by copy & paste or drag & drop again. Virtual Folders fills automatically with your Documents in your desired format and product scope. Keep track of Submissions and Audits anytime.

Pre-Configured for EU-MDR, FDA, etc.
Configuration of your own structures
Automated Updates of Submissions
No document redundancies

Let the Inspectors work for you!

Data can be validated, Documents checked for up to dateness and Folder Structures or Submissions monitored for correct data.

Data Validation
Document Monitoring
Folder & Submission Tracking

Manage QM-Processes synced to your eTD!

Technical Documentation connected to your QM Processes gives you deep data insight and tracking capabilities.

Change Documentation
CAPA Documentation
Complaint Documentation
Setup Custom Processes
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Take a look at the most sophisticated solution developed specifically for medical devices and IVD.
1. Create Account  |  2. DEMO  |  3. Workspace Setup
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