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

MedTech companies
trust Essenvia to achieve Regulatory Excellence

Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.

MedTech companies
trust Essenvia to achieve Regulatory Excellence

Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.

MedTech companies
trust Essenvia to achieve Regulatory Excellence

Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.

MedTech companies
trust Essenvia to achieve Regulatory Excellence

Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.

350+

Submissions prepared with
the Essenvia RIM Platform

350+

Submissions prepared with the Essenvia RIM Platform

350+

Submissions prepared with
the Essenvia RIM Platform

350+

Submissions prepared with
the Essenvia RIM Platform

100+

New medical devices
brought to market

100+

New medical devices brought to market

100+

New medical devices
brought to market

100+

New medical devices
brought to market

100%

Submission
acceptance rate

100%

Submission acceptance rate

100%

Submission
acceptance rate

100%

Submission
acceptance rate

Essenvia Customer for 3+ Years

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.”

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 Landsdown

Director of Quality, Regulatory, and Compliance

Essenvia Customer for 2+ Years

With the help of the Essenvia Platform, we have successfully obtained clearance both in the UK and in the EU! Essenvia has truly been instrumental in our success, and we are grateful for your continued support.”

With the help of the Essenvia Platform, we have successfully obtained clearance both in the UK and in the EU! Essenvia has truly been instrumental in our success, and we are grateful for your continued support.”

VP of Clinical, Regulatory, and Quality Affairs

A global publicly traded In Vitro Diagnostics company

Navigate the complex world of regulatory compliance with confidence.

Navigate the complex world of regulatory compliance with confidence.

Navigate the complex world of regulatory compliance with confidence.

Essenvia Customer for 3+ Years

We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to Essenvia, 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.”

We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to Essenvia, 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.”

Marta Stepien

VP of Clinical, Regulatory, and Quality Affairs

Essenvia Customer for 2+ Years

Essenvia's PMA automation tool has revolutionized our regulatory affairs operations. By streamlining administrative tasks and enhancing data visibility, we saved time and improved accuracy. The eSTAR and RIM systems ensure 100% submission accuracy and project tracking, while the submission edit features expedite processes and facilitate collaboration. They provided exceptional customer service, and the Essenvia technology exceeded our expectations, proving to be an invaluable asset to our company.”

Essenvia's PMA automation tool has revolutionized our regulatory affairs operations. By streamlining administrative tasks and enhancing data visibility, we saved time and improved accuracy. The eSTAR and RIM systems ensure 100% submission accuracy and project tracking, while the submission edit features expedite processes and facilitate collaboration. They provided exceptional customer service, and the Essenvia technology exceeded our expectations, proving to be an invaluable asset to our company.”

VP of Clinical and Regulatory Affairs

A global leader in the preservation and perfusion of organs

Accelerate global market access, reduce costs, and focus on what your company does best: Innovation!

Accelerate global market access, reduce costs, and focus on what your company does best: Innovation!

Accelerate global market access, reduce costs, and focus on what your company does best: Innovation!