Accelerate your 510(k)
submissions and quickly
adapt to eSTAR
Transitioning your 510(k) submissions to eSTAR has never
been easier with Essenvia’s eSTAR submission builder.
Accelerate your 510(k)
submissions and quickly
adapt to eSTAR
Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.
Accelerate your 510(k)
submissions and quickly
adapt to eSTAR
Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.
Accelerate your 510(k)
submissions and quickly
adapt to eSTAR
Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.
- 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
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
eSTAR mandatory
starting Oct 1, 2023
eSTAR mandatory
starting Oct 1, 2023
eSTAR mandatory
starting Oct 1, 2023
eSTAR mandatory
starting Oct 1, 2023
All FDA 510(k) submissions must be submitted via eSTAR starting in October.
eSTAR PDF challenges:
- Occasionally blanks out entered information
- Slows down with every attachment
- Doesn't check for errors
- Can be edited one person at a time
- New version every 2-3 months
All FDA 510(k) submissions must be submitted via eSTAR starting in October.
eSTAR PDF challenges:
- Occasionally blanks out entered information
- Slows down with every attachment
- Doesn't check for errors
- Can be edited one person at a time
- New version every 2-3 months
All FDA 510(k) submissions must be submitted via eSTAR starting in October.
eSTAR PDF challenges:
- Occasionally blanks out entered information
- Slows down with every attachment
- Doesn't check for errors
- Can be edited one person at a time
- New version every 2-3 months
Easily adapt to eSTAR
Essenvia walks you through every step of your eSTAR submission, checks for errors, and instantly generates a native preview of your eSTAR file:
Easy digital walkthrough of every eSTAR question
Map your custom templates to eSTAR
Edit your eSTAR live with multiple stakeholders
Map and auto-update all attachments
One-click preview of native eSTAR file
Easily adapt to eSTAR
Essenvia walks you through every step of your eSTAR submission, checks for errors, and instantly generates a native preview of your eSTAR file:
Easy digital walkthrough of every eSTAR question
Map your custom templates to eSTAR
Edit your eSTAR live with multiple stakeholders
Map and auto-update all attachments
One-click preview of native eSTAR file
Easily adapt to eSTAR
Essenvia walks you through every step of your eSTAR submission, checks for errors, and instantly generates a native preview of your eSTAR file:
Easy digital walkthrough of every eSTAR question
Map your custom templates to eSTAR
Edit your eSTAR live with multiple stakeholders
Map and auto-update all attachments
One-click preview of native eSTAR file
Easily adapt to eSTAR
Essenvia walks you through every step of your eSTAR submission, checks for errors, and instantly generates a native preview of your eSTAR file:
Easy digital walkthrough of every eSTAR question
Map your custom templates to eSTAR
Edit your eSTAR live with multiple stakeholders
Map and auto-update all attachments
One-click preview of native eSTAR file
Save Time
Send file requests to collaborators, letting them upload and share technical files directly into your eSTAR project:
Gather files ahead of deadlines with continuous alerts
Reduce time-consuming searches for information
All attachments auto-update when files change
Auto-convert files to compliant formats
Files available for multiple submissions
Manage access on account, device, section levels
Save Time
Send file requests to collaborators, letting them upload and share technical files directly into your eSTAR project:
Gather files ahead of deadlines with continuous alerts
Reduce time-consuming searches for information
All attachments auto-update when files change
Auto-convert files to compliant formats
Files available for multiple submissions
Manage access on account, device, section levels
Save Time
Send file requests to collaborators, letting them upload and share technical files directly into your eSTAR project:
Gather files ahead of deadlines with continuous alerts
Reduce time-consuming searches for information
All attachments auto-update when files change
Auto-convert files to compliant formats
Files available for multiple submissions
Manage access on account, device, section levels
Save Time
Send file requests to collaborators, letting them upload and share technical files directly into your eSTAR project:
Gather files ahead of deadlines with continuous alerts
Reduce time-consuming searches for information
All attachments auto-update when files change
Auto-convert files to compliant formats
Files available for multiple submissions
Manage access on account, device, section levels
100% Assurance
Essenvia’s submission templates have a 100% acceptance rate with the US and EU regulatory bodies
100% Assurance
Essenvia’s submission templates have a 100% acceptance rate with the US and EU regulatory bodies
100% Assurance
Essenvia’s submission templates have a 100% acceptance rate with the US and EU regulatory bodies
Submit 33% Faster
with Re-Usable Data
Go faster with each submission, by storing and re-using past submission information in new submissions:
Company information
Device information
Regulatory information
Submission data and attachments
Submit 33% Faster
with Re-Usable Data
Go faster with each submission, by storing and re-using past submission information in new submissions:
Company information
Device information
Regulatory information
Submission data and attachments
Submit 33% Faster
with Re-Usable Data
Go faster with each submission, by storing and re-using past submission information in new submissions:
Company information
Device information
Regulatory information
Submission data and attachments
Submit Faster
with Re-Usable Data
Go faster with each submission, by storing and re-using past submission information in new submissions:
Company information
Device information
Regulatory information
Submission data and attachments
Get Regulatory Alerts
Put research on autopilot with regulatory alerts directly from regulatory authority data feeds including:
510(k) summaries
New and updated standards, guidance documents
New or existing competitive intelligence
Get Regulatory Alerts
Put research on autopilot with regulatory alerts directly from regulatory authority data feeds including:
510(k) summaries
New and updated standards, guidance documents
New or existing competitive intelligence
Get Regulatory Alerts
Put research on autopilot with regulatory alerts directly from regulatory authority data feeds including:
510(k) summaries
New and updated standards, guidance documents
New or existing competitive intelligence
Get Regulatory Alerts
Put research on autopilot with regulatory alerts directly from regulatory authority data feeds including:
510(k) summaries
New and updated standards, guidance documents
New or existing competitive intelligence
Zero Implementation. Start Today.
Start your eSTAR submission in minutes - with Essenvia there is no technical implementation required:
Start now, integrate later
eSTAR ready with one click
No training needed to get started
No IT implementation
Transition to eSTAR in minutes
Zero Implementation.
Start Today.
Start your eSTAR submission in minutes - with Essenvia there is no technical implementation required:
Start now, integrate later
eSTAR ready with one click
No training needed to get started
No IT implementation
Transition to eSTAR in minutes
Zero Implementation. Start Today.
Start your eSTAR submission in minutes - with Essenvia there is no technical implementation required:
Start now, integrate later
eSTAR ready with one click
No training needed to get started
No IT implementation
Transition to eSTAR in minutes
Zero Implementation.
Start Today.
Start your eSTAR submission in minutes - with Essenvia there is no technical implementation required:
Start now, integrate later
eSTAR ready with one click
No training needed to get started
No IT implementation
Transition to eSTAR in minutes
Re-use MDR data in new eSTAR 510(k) submissions
Re-use European submission data in new eSTAR submissions with intelligent mapping across:
Company information
Device information
Regulatory information
Other data and technical files
Re-use MDR data in new eSTAR 510(k) submissions
Re-use European submission data in new eSTAR submissions with intelligent mapping across:
Company information
Device information
Regulatory information
Other data and technical files
Re-use MDR data in new eSTAR 510(k) submissions
Re-use European submission data in new eSTAR submissions with intelligent mapping across:
Company information
Device information
Regulatory information
Other data and technical files
Re-use MDR data in new eSTAR 510(k) submissions
Re-use European submission data in new eSTAR submissions with intelligent mapping across:
Company information
Device information
Regulatory information
Other data and technical files