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Automate your Technical Documentation

Regulatory End-to-End Process. From Data to Submission.
Single Source of Truth, no Redundancies, Re-Useable Data
Intelligent Documents and Auto-Updates
Automated Submission structures: EU-MDR, FDA, etc.
Monitoring of Data, Documents and Submissions
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Sync your Quality with eTD

Run Changes, CAPA, Complaints and Custom Processes directly in the system.
Gain maximum Insight due to full eQMS and eTD sync.
Decrease process time and administrative burden to a minimum.
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Your Technical Documentation on Autopilot

eTD Workflow for Medical Devices
Outstanding regulatory affairs workflow for medical devices. True Digital Technical Documentation from Data to Submission.
Intelligent Writer to automate your Documents
Next Generation of Documents are intelligent. Bring in the full logic of eTD to your Documents. Automate Data and Tables to focus on more important tasks.
Audit & Submission Management
Track dates and see the delta between submitted and current state of your technical documentation.
Additional Apps to put TD on Autopilot (GSPR Manager)
Constantly evolving features and modules to help you to manage your eTD top notch digital. Examples: GSPR Manager, Standard Manager, etc.
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Medical Device Regulation
Überprüfungen von Klasse I Herstellern durch Behörden laufen vermehrt an. Was derzeit passiert und was man unbedingt beachten sollte.
Medical Device Regulation
Systems and Procedure Packs under MDR
Medical Device Regulation
State of the art GSPR
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RA & QA

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eTD and eQMS solutions for medical devices
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