Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

Quick Survey

Ready for FDA eSTAR?

The survey takes 5 minutes, and respondents will receive the final report firsthand.

Quick Survey

Ready for FDA eSTAR?

The survey takes 5 minutes, and respondents will receive the final report firsthand.

Quick Survey

Ready for FDA eSTAR?

The survey takes 5 minutes, and respondents will receive the final report firsthand.

Quick Survey

Ready for FDA eSTAR?

The survey takes 5 minutes, and respondents will receive the final report firsthand.

The Leading Platform to
Accelerate MedTech

Regulatory Submissions

Start using Essenvia today to accelerate

the clearance of your FDA 510(k) submissions

and EU MDR & IVDR CE certifications.

The Leading Platform to
Accelerate MedTech

Regulatory Submissions

Start using Essenvia today to accelerate the approval of your 510(k) and MDR applications and get your medical devices to market faster.

The Leading Platform to
Accelerate MedTech

Regulatory Submissions

Start using Essenvia today to accelerate the approval of your 510(k) and MDR applications and get your medical devices to market faster.

The Leading Platform to
Accelerate MedTech

Regulatory Submissions

Start using Essenvia today to accelerate the approval of your 510(k) and MDR applications and get your medical devices to market faster.

FDA now accepts all 510(k)'s via eSTAR
FDA now accepts all 510(k)'s via eSTAR
FDA now accepts all 510(k)'s via eSTAR
FDA now accepts all 510(k)'s via eSTAR

FDA 510(k) Clearance

FDA 510(k) Clearance

FDA 510(k) Clearance

Use Essenvia to easily transition your 510(k) submissions to eSTAR 

Use Essenvia to easily transition your 510(k) submissions to eSTAR 

Use Essenvia to easily transition your 510(k) submissions to eSTAR 

New EUMDR and IVDR submission requirements are going into effect
New EUMDR and IVDR submission requirements are going into effect
New EUMDR and IVDR submission requirements are going into effect
New EUMDR and IVDR submission requirements are going into effect

EUMDR/IVDR

EUMDR/IVDR

EUMDR/IVDR

Use Essenvia to rapidly create your EUMDR/IVDR  submissions

Use Essenvia to rapidly create your EUMDR/IVDR  submissions

Use Essenvia to rapidly create your EUMDR/IVDR  submissions

Why
Essenvia?


Zero Implementation

Start using Essenvia today and realize benefits in the first week




Faster Submissions

Save up to 4 weeks per submission and get your medical devices to market faster



100% Assurance

Essenvia has been used in more than 300 submissions with a 100% acceptance rate


Why
Essenvia?


Zero Implementation

Start using Essenvia today and realize benefits in the first week




Faster Submissions

Save up to 4 weeks per submission and get your medical devices to market faster



100% Assurance

Essenvia has been used in more than 300 submissions with a 100% acceptance rate


Why
Essenvia?


Zero Implementation

Start using Essenvia today and realize benefits in the first week




Faster Submissions

Save up to 4 weeks per submission and get your medical devices to market faster



100% Assurance

Essenvia has been used in more than 300 submissions with a 100% acceptance rate


Why
Essenvia?


Zero Implementation

Start using Essenvia today and realize benefits in the first week




Faster Submissions

Save up to 4 weeks per submission and get your medical devices to market faster



100% Assurance

Essenvia has been used in more than 300 submissions with a 100% acceptance rate


"Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits and even major updates at the last minute for very complex submissions.

We can’t live without the platform.”

JOHN LANSDOWN

GM - Quality, Regulatory and Compliance

"Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits and even major updates at the last minute for very complex submissions.

We can’t live without the platform.”

JOHN LANSDOWN

GM - Quality, Regulatory and Compliance

"Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits and even major updates at the last minute for very complex submissions.

We can’t live without the platform.”

JOHN LANSDOWN

GM - Quality, Regulatory and Compliance

Get 30%+ Faster with
Every Submission

Get 30%+ Faster with Every Submission

Easily assemble complex libraries of technical files and auto-complete large portions of new submissions by re-using documents and device information from past submissions in your master library.

Accelerate new regulatory submissions with Essenvia's master data library
Regulatory submission review requests on Essenvia

Save 4+ Weeks per Submission

Have technical files and content come to you by requesting stakeholder contributions and by bringing all stakeholders in parallel, safely, and securely into your regulatory submission drafting process.

Save 4+ Weeks per Submission

Have technical files and content come to you by requesting stakeholder contributions and by bringing all stakeholders in parallel, safely, and securely into your regulatory submission drafting process.

Save 4+ Weeks per Submission

Have technical files and content come to you by requesting stakeholder contributions and by bringing all stakeholders in parallel, safely, and securely into your regulatory submission drafting process.

Save 4+ Weeks per Submission

Have technical files and content come to you by requesting stakeholder contributions and by bringing all stakeholders in parallel, safely, and securely into your regulatory submission drafting process.

Get 100% Acceptance

Intelligent in-line error checking, intuitive walk-through wizards and proven yet customizable templates maximize acceptance by eliminating common rejection issues.

Get 100% Acceptance

Intelligent in-line error checking, intuitive walk-through wizards and proven yet customizable templates maximize acceptance by eliminating common rejection issues.

Get 100% Acceptance

Intelligent in-line error checking, intuitive walk-through wizards and proven yet customizable templates maximize acceptance by eliminating common rejection issues.

Get 100% Acceptance

Intelligent in-line error checking, intuitive walk-through wizards and proven yet customizable templates maximize acceptance by eliminating common rejection issues.

Intelligent regulatory submission error checking on Essenvia
Mine regulatory submission intelligence directly from regulatory body data feeds

Monitor Competitors & Regulatory Changes

Create intelligent alerts for competitors, indications, recalls and other events, bringing relevant market information to you directly from the regulatory authority’s data feeds.

Monitor Competitors & Regulatory Changes

Create intelligent alerts for competitors, indications, recalls and other events, bringing relevant market information to you directly from the regulatory authority’s data feeds.

Monitor Competitors & Regulatory Changes

Create intelligent alerts for competitors, indications, recalls and other events, bringing relevant market information to you directly from the regulatory authority’s data feeds.

Monitor Competitors & Regulatory Changes

Create intelligent alerts for competitors, indications, recalls and other events, bringing relevant market information to you directly from the regulatory authority’s data feeds.

Zero Implementation. Start Today.

Essenvia requires no implementation to get going, which means you get going faster.

We did it smart. And we keep it simple.

Zero Implementation.
Start Today.

Essenvia requires no implementation to get going, which means you get going faster.

We did it smart. And we keep it simple.

Zero Implementation. Start Today.

Essenvia requires no implementation to get going, which means you get going faster.

We did it smart. And we keep it simple.

Zero Implementation. Start Today.

Essenvia requires no implementation to get going, which means you get going faster.

We did it smart. And we keep it simple.

Zero implementation - get started with Essenvia on day one
Zero implementation - get started with Essenvia on day one