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 duplicating content and reviewing 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 Dropbox, Box, and Sharepoint
How Essenvia Speeds Up The Process
AND Reduces Errors
Supplying MDR Approved Templates
We will always provide the most up to date MDR 2017/45 templates.
Limiting Repetitive
Data Entry
After you enter key information once, we cascade it through the rest of your application.
Locking In
Key Changes
Avoid discrepancies by ensuring your changes take hold in the appropriate places
Providing Much Needed
Flexibility
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
Testimonials
If you need regulatory clearance, you’d be foolish not to use Essenvia.
The organizing, paginating, and document formatting alone makes Essenvia a must-have.
As a former FDA reviewer turned Regulatory Consultant, this web-based platform is a game changer for anyone submitting to the FDA.