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

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.

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

FDA eSTAR format required for all 510k submissions starting October 1 2023
FDA eSTAR format required for all 510k submissions starting October 1 2023
FDA eSTAR format required for all 510k submissions starting October 1 2023

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

Essenvia's 510k eSTAR builder is an intuitive digital walkthrough of the entire eSTAR form
Essenvia's 510k eSTAR builder is an intuitive digital walkthrough of the entire eSTAR form
Essenvia's 510k eSTAR builder is an intuitive digital walkthrough of the entire eSTAR form
Essenvia's 510k eSTAR builder is an intuitive digital walkthrough of the entire eSTAR form
Review all submission requests in your queue - Essenvia
Review all submission requests in your queue - Essenvia
Review all submission requests in your queue - Essenvia
Review all submission requests in your queue - Essenvia

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

Essenvia's master data library intelligently re-uses submission information
Essenvia's master data library intelligently re-uses submission information
Essenvia's master data library intelligently re-uses submission information
Essenvia's market intelligence allows you to mine data directly from regulatory authority data feeds
Essenvia's market intelligence allows you to mine data directly from regulatory authority data feeds
Essenvia's market intelligence allows you to mine data directly from regulatory authority data feeds
Essenvia's market intelligence allows you to mine data directly from regulatory authority data feeds

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

Essenvia has no implementation - so you can get started with your regulatory submissions on day one
Essenvia has no implementation - so you can get started with your regulatory submissions on day one
Re-use EUMDR data for US FDA eSTAR submissions
Re-use EUMDR data for US FDA eSTAR submissions
Re-use EUMDR data for US FDA eSTAR submissions
Re-use EUMDR data for US FDA eSTAR submissions

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