How The 510(k) Application Builder
Makes Your Job Easier
Microsoft and Adobe products were not made for 510(k) submissions. Our solution eliminates formatting headaches for a professional-looking and error-free application.
- Up To Date FDA Templates
- Pre-Formatted Documents
- One Click To Submit Your eCopy
More than 30% of 510(k) Submissions are rejected due to manual input errors. Our software is proven to eliminate manual errors by ensuring your key data points remain consistent throughout your application.
- 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
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.
- Reduces chances of mis-numbering tables or figures
- Avoids wasting time double checking your changes
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.
- 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 FDA 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.
Essenvia At Glance
Eliminates errors by reducing manual data entry
Handles repetitive, administrative tasks
Provides real-time status updates to project stakeholders
Centralizes team contributions in one place
Gets your device to market faster by increasing efficiency
Creates an accurate and professional looking application, ready for submission
If you need regulatory clearance, you’d be foolish not to use Essenvia.
The biggest advantage is the support!
The built-in reference and linking features eliminated my cross-referencing headaches.