Our eSTAR interface is changing the game on FDA 510(k) submissions

Our eSTAR interface is changing the game on FDA 510(k) submissions

Our eSTAR interface is changing the game on FDA 510(k) submissions

Our eSTAR interface is changing the game on FDA 510(k) submissions

Essenvia allows
collaborative authoring
and simultaneous users
on FDA eSTAR submissions

Essenvia’s novel eSTAR submissions builder shortens time to market
and ensures business success. Start using our unique technology
to streamline your 510(k) eSTAR submissions and get a
100% submission acceptance rate.

Essenvia allows
collaborative authoring
and simultaneous users
on FDA eSTAR submissions

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

Essenvia allows
collaborative authoring
and simultaneous users
on FDA eSTAR submissions

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

Essenvia allows
collaborative authoring
and simultaneous users
on FDA eSTAR submissions

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

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

Submission challenges using FDA’s eSTAR can overwhelm and frustrate because Adobe interface:

- Occasionally blanks out entered information
- Slows down with every attachment
- Doesn't check for errors
- Can be edited one person at a time

- Occasionally blanks out entered information
- Slows down with every attachment
- Doesn't check for errors
- Can be edited one person at a time

- Occasionally blanks out entered information
- Slows down with every attachment
- Doesn't check for errors
- Can be edited one person at a time


Let Essenvia shoulder the burden for you!

"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 they´re 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 they´re 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 they´re 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

Easily adapt to eSTAR

It’s easy and intuitive to use Essenvia’s eSTAR builder. In no time, cross-functional teams within your organization will find it extremely efficient and be an invaluable tool for regulatory and submissions functions.

Here’s just a taste of what Essenvia can do for your company:

  • Provides an easy digital walkthrough of every step

  • Map your custom templates to eSTAR

  • Edit your eSTAR live with multiple stakeholders

  • Map and auto-update all attachments

  • Gives a one-click preview of the native eSTAR file

Easily adapt to eSTAR

It’s easy and intuitive to use Essenvia’s eSTAR builder. In no time, cross-functional teams within your organization will find it extremely efficient and be an invaluable tool for regulatory and submissions functions.

Here’s just a taste of what Essenvia can do for your company:

  • Provides an easy digital walkthrough of every step

  • Map your custom templates to eSTAR

  • Edit your eSTAR live with multiple stakeholders

  • Map and auto-update all attachments

  • Gives a one-click preview of the native eSTAR file

Easily adapt to eSTAR

It’s easy and intuitive to use Essenvia’s eSTAR builder. In no time, cross-functional teams within your organization will find it extremely efficient and be an invaluable tool for regulatory and submissions functions.

Here’s just a taste of what Essenvia can do for your company:

  • Provides an easy digital walkthrough of every step

  • Map your custom templates to eSTAR

  • Edit your eSTAR live with multiple stakeholders

  • Map and auto-update all attachments

  • Gives a one-click preview of the native eSTAR file

Easily adapt to eSTAR

It’s easy and intuitive to use Essenvia’s eSTAR builder. In no time, cross-functional teams within your organization will find it extremely efficient and be an invaluable tool for regulatory and submissions functions.

Here’s just a taste of what Essenvia can do for your company:

  • Provides an easy digital walkthrough of every step

  • Map your custom templates to eSTAR

  • Edit your eSTAR live with multiple stakeholders

  • Map and auto-update all attachments

  • Gives a one-click preview of the 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

Learn more Essenvia’s resource-saving eSTAR platform

Want to learn more about the
Essenvia RIM Platform?

Let Essenvia fix your eSTAR problems today.
Contact us now for a free demo.

Let Essenvia fix your eSTAR problems today.
Contact us now for a free demo.

Let Essenvia fix your eSTAR problems today.
Contact us now for a free demo.