Regulatory Submissions and Registrations

meddevo eSubmissions

Redundant free dossiers for flawless country registration and TD reviews

Automate the creation of TechFiles and registration dossiers, saving you hours of work and ensuring flawless submissions for your medical devices and IVDs.

Automatic TechFile Creation

Create a registration TechFile in minutes instead of hours

Country Specific Templates

Pre-configured folder templates for each target country

Monitoring & Updates

Never miss an update that you should have reported to the country

Automated Creation

Automated creation of Registrations

Create a registration TechFile in minutes instead of hours. meddevo eSubmissions will curate a TechFile automatically based on your desired product and regulatory framework selected.

All registrations are supervised by meddevo monitoring. So you will never miss an update in your file that you should have reported to the country.

  • Automatic creation of Dossiers
  • Country specific folder templates
  • Monitoring for current up to dateness
eSubmissions Platform
TechFile Infusion sets

Select Product

Medical Device XYZ

Target Country

Germany
Submission Generated Successfully

14 documents • 3 minutes saved

Registration Workflow
Products
Complete
Choose Regulatory Framework
Complete
Create Submission
In Progress
Review & Submit
Pending
Effortless Creation

Create Registrations in Minutes

With eSubmissions, you can create a registration in minutes. Simply select your desired products and country, and eSubmissions will curate a TechFile automatically.

Plus, with meddevo monitoring, you'll never miss an update that you should have reported to the country. Our automated system keeps track of all changes and notifies you when action is required.

Minutes instead of hours for Submission creation
Product and country configurations
Real-time monitoring for compliance updates
Stay Up to Date

Review All Registrations Your Way

You can review all registrations the way you want. The meddevo data management gives you the choice. Save as many views as you like and share them with your colleagues.

Dynamic Overview

Get a complete view of all your registrations with customizable dashboards and real-time status updates.

Registration Data Management

Manage all your registration data in one centralized location with powerful filtering and search capabilities.

Customizable Process

Adapt the registration process to your workflow. Create custom views, filters, and save your preferred configurations.

Seamless Integration

Connected to Your Automated eTD

eSubmissions is connected to your automated eTD, ensuring seamless integration and consistency across your documentation. With eSubmissions, you can streamline your process, improve efficiency, and ensure your medical devices and IVDs meet the highest standards of compliance.

Changes in your eTD are automatically reflected in your registrations, eliminating manual updates and reducing the risk of inconsistencies.

Automatic synchronization with eTD
Consistent documentation across all registrations
Real-time updates when source documents change
Reduced manual work and error prevention
eTD Integration
eTD Source Documents

Technical Documentation

Registration TechFiles

Auto-generated & synced

EUUSAJPBRAU
Platform Features

Streamlining Your Medical Device and IVD Registrations

Experience the power of automation for your country registration and TD reviews

Automated TechFile Creation

Create registration TechFiles in minutes. Select products and country, and let eSubmissions do the rest.

Country-Specific Templates

Pre-configured folder structures and templates for each target market's regulatory requirements.

Continuous Monitoring

Never miss an update. Our system monitors your registrations and alerts you to required changes.

Dynamic Dashboards

Review all registrations with customizable views. Save and share configurations with your team.

eTD Integration

Seamlessly connected to your automated eTD for consistent documentation across all submissions.

Team Collaboration

Share views and configurations with colleagues. Everyone stays informed and aligned.

By the Numbers

Transforming Registration Workflows

90%

Time saved on Submission creation

100%

Monitoring coverage for updates

Country templates configurable

Embrace the Future

Transform Your Registration Process

Are you ready to transform your registration process? Experience the power of automation with eSubmissions. Discover how our software can revolutionize your country registration and TD review process.

Navigating the complexities of country registration and technical documentation (TD) reviews for medical devices and IVDs can be a daunting task. That's where eSubmissions comes in.

Our software solution is designed to automate the creation of TechFiles and registration dossiers, saving you hours of work and ensuring flawless submissions.

Hours Saved Weekly

Create TechFiles in minutes instead of hours of manual work

Flawless Submissions

Automated creation ensures consistency and reduces errors

Global Compliance

Country-specific templates ensure regulatory compliance worldwide

Get Started

Start Automating Your Registrations Today

Join medical device companies who have transformed their registration workflow with eSubmissions.

1

Request a demo of eSubmissions

2

See automated TechFile creation in action

3

Configure for your products and countries

4

Start saving hours on every registration

Ready to streamline your registrations?

meddevo eSubmissions automates TechFile creation and registration dossiers for medical devices and IVDs.
Save hours of work. Ensure flawless submissions.

No credit card required. See the demo to learn more.