Available Now: Free eSTAR Office Hours with our experts

Available Now: Free eSTAR Office Hours with our experts

Available Now: Free eSTAR Office Hours with our experts

Available Now: Free eSTAR Office Hours with our experts

World´s only Platform to
Automate FDA eSTAR
Submissions

Start using Essenvia today to simplify the

transition of your 510(k) submissions to eSTAR.

World´s only Platform to
Automate FDA eSTAR
Submissions

Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.

World´s only Platform to
Automate FDA eSTAR
Submissions

Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.

World´s only Platform to
Automate FDA eSTAR
Submissions

Transitioning your 510(k) submissions to eSTAR has never been easier with Essenvia’s eSTAR submission builder.

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE
MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

Regulatory submission review requests on Essenvia
Regulatory submission review requests on Essenvia
Regulatory submission review requests on Essenvia
Regulatory submission review requests on Essenvia

Why Choose the
Essenvia RIM Platform?

Why Choose the
Essenvia RIM Platform?

Why Choose the
Essenvia RIM Platform?

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Easy to implement and to integrate with your QMS, CRM, or PLM.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

"We completed and successfully submitted our first FDA eSTAR submission using Essenvia.  Thanks to this Platform our team was able to work together in one single place at any time to author, edit, and review the submission. As a regulatory leader, I also love seeing the total progress of the submission and individual sections as it’s being prepared and completed.

Once the submission was ready in the Essenvia Platform, we were able to instantly publish it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."

"We completed and successfully submitted our first FDA eSTAR submission using Essenvia.  Thanks to this Platform our team was able to work together in one single place at any time to author, edit, and review the submission. As a regulatory leader, I also love seeing the total progress of the submission and individual sections as it’s being prepared and completed.

Once the submission was ready in the Essenvia Platform, we were able to instantly publish it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."

"We completed and successfully submitted our first FDA eSTAR submission using Essenvia.  Thanks to this Platform our team was able to work together in one single place at any time to author, edit, and review the submission. As a regulatory leader, I also love seeing the total progress of the submission and individual sections as it’s being prepared and completed.

Once the submission was ready in the Essenvia Platform, we were able to instantly publish it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."

MARTA STEPIEN

MARTA STEPIEN

MARTA STEPIEN

VP of Clinical, Regulatory and Quality Affairs

VP of Clinical, Regulatory and Quality Affairs

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