How The 510(k) Application Builder
Makes Your Job Easier

Simplifies Formatting

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

Improves Accuracy

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

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.


  • 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.


  • 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


Supplying Correct

We will always provide the most up to date FDA 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.

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


If you need regulatory clearance, you’d be foolish not to use Essenvia.

– Michelle Lott, RAC

Founder and Principal

The biggest advantage is the support!

– Robert Futch

Chief Technology Officer
Delta Development Inc.

The built-in reference and linking features eliminated my cross-referencing headaches.

– Lynsie Thomason

Director of Product Management
Innovere Medical Inc.