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.
Zero Implementation. Start Using Today.
Zero Implementation. Start Using Today.
Zero Implementation. Start Using Today.
Zero Implementation. Start Using Today.
- Company logo of Vios
- Company logo of Sleepiz
- Company logo of Vios
- Company logo of Sleepiz
- Company logo of Vios
- Company logo of Sleepiz
- Company logo of Vios
- Company logo of Sleepiz
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
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.
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.
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.
