Finally, You Can Complete an Accurate
and Pain-Free MDR / IVDR Tech File –Much
Faster!
We’re all about increasing accuracy AND speeding up your process.
How The MDR / IVDR Tech File Builder
Makes Your Job Easier
Simplifies Formatting
Microsoft, Adobe products and traditional RIMS solutions were not made for managing Medical Device regulatory affairs. Our solution helps you build and produce / publish an error free MDR / IVDR Technical Document that you can submit to your Notified Body in seconds.
Features
Provides up to date extensive templates compliant with MDR 2017/745 and IVDR 2017/746
Easily add, embed files and reports directly into pre-formatted templates approved by all Notified Bodies
Provides Flexibility
Our flexible templates can be adjusted to accommodate the needs of your Notified Body. You can add sections and save your template for future use.
Features
Editable versions of up-to-date templates
Ability to save all necessary templates in an easy-to-access library
Improves Accuracy
An alarming number of MDR / IVDR submissions are sent back or experience extended review timelines due to administrative errors. Our software is proven to eliminate manual errors by ensuring your key data points remain consistent throughout your application.
Features
Enter key data such as company, device, and regulatory information once per medical device
Platform will cascade key data and changes into appropriate sections for all your applications for the device
Ensures Consistency
Never again re-enter information when you make a change. Instead, change it once – and the application builder cascades the edit throughout the document, ensuring accuracy and consistency. Existing tables and figures are automatically re-numbered when you add new one and move them from one section to another.
Features
Reduces chances of mis-numbering tables or figures
Avoids wasting time double checking your changes
Improves Collaboration
Collecting data from cross-functional teams can be overwhelming. Now your team can upload key documents directly into the application. Then, review these documents and provide real-time feedback to your team members – all within our platform.
Features
Combines all project communication into one place
Provides percent-to-completion status to all stakeholders
Integrates with file sharing platforms such as Dropbox, Box, and Sharepoint
How Essenvia Speeds Up The Process
AND Reduces Errors
We will always provide the most up to date MDR 2017/45 templates.
After you enter key information once, we cascade it through the rest of your application.
Avoid discrepancies by ensuring your changes take hold in the appropriate places.
Leverage our flexible template to ensure confidence when submitting to your Notified Body.
Essenvia At Glance
Improves Accuracy
Eliminates errors by reducing manual data entry
Saves Time
Handles repetitive, administrative tasks
Increases Transparency
Provides real-time status updates to project stakeholders
Promotes Collaboration
Centralizes team contributions in one place
Expedites Clearance
Gets your device to market faster by increasing efficiency
Delivers Perfection
Creates an accurate and professional looking application, ready for submission
