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

Reduce your time to submission and get 100% acceptance rate

Essenvia´s unique and patented technolgy supercharges global regulatory submissions, including the new FDA eSTAR submission process and the transition to MDR.

Reduce your time to submission and get 100% acceptance rate

AI-powered SSupercharge the new FDA eSTAR submission process and master the transition to MDR.

Reduce your time to submission and get 100% acceptance rate

Supercharge the new FDA eSTAR submission process and master the transition to MDR.

Reduce your time to submission and get 100% acceptance rate

AI-powered SSupercharge the new FDA eSTAR submission process and master the transition to MDR.

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE
MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

How can the Essenvia RIM Platform help you manage your regulatory submissions?

How can the Essenvia RIM Platform help you manage your regulatory submissions?

How can the Essenvia RIM Platform help you manage your regulatory submissions?

Battle-tested Templates

Extensive library of templates compliant
with all regulations and countries.

Extensive library of templates compliant
with all regulations and countries.

Reusable Content Automation

Automation of reusable content across submissions and integration with eQMS/PLM (also on eSTAR submissions).

Automation of reusable content across submissions and integration with eQMS/PLM (also on eSTAR submissions).

Essenvia is the only platform on the planet that allows collaborative work on eSTAR submissions (thanks to our patented technology).

100% Acceptance Rate

Instantly generate final submission files with 1-Click.
100% submission acceptance rate.

Instantly generate final submission files with 1-Click.
100% submission acceptance rate.

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

Want to learn more about the Essenvia RIM Platform?

Want to learn more about the
Essenvia RIM Platform?

Contact us for a Free Demo!

Contact us for a Free Demo!

Contact us for a Free Demo!