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
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
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