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

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

Discover More

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

Discover More

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

Discover More

Customers

MedTech companies trust Essenvia to achieve Regulatory Excellence

The Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.

Case Study

10,000s

10,000s

10,000s

Products and licenses managed on

the Essenvia RIM Platform

Submissions prepared with the Essenvia RIM Platform

1,000s

1,000s

1,000s

Global Submissions accelerated
with Essenvia's Submissions AI

New medical devices brought to market

100%

100%

100%

Submission
acceptance rate

Submission acceptance rate

Utilizing Essenvia RIMS AI

“

Essenvia RIM is easy to use and fast to setup. We save at least 20% of our time with using Essenvia RIMS capabilities. Our experience with other RIMS tools made day-to-day operations more complex did not fit into our internal workflows. The Essenvia platform is so intuitive and easy to use - that our team's adoption reached over 90% within 2 months from implementation.”

Essenvia RIM is easy to use and fast to setup. We save at least 20% of our time with using Essenvia RIMS capabilities. Our experience with other RIMS tools made day-to-day operations more complex did not fit into our internal workflows. The Essenvia platform is so intuitive and easy to use - that our team's adoption reached over 90% within 2 months from implementation.”

SEJAL CHITRE

Director Global Regulatory Affairs

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 Lansdown

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

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.”

VP of Clinical, Regulatory and Quality Affairs

EU company focused in patient-centric disease management through technology

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 publicly traded global leader in the preservation and perfusion of organs