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

The smart way to manage the impact of changes in your medical devices

The smart way to manage the impact of changes in your medical devices

The smart way to manage the impact of changes in your medical devices

The smart way to manage the impact of changes in your medical devices

The Essenvia RIM Platform allows you to easily manage change assessment and streamline collaboration between regulatory and other departments (e.g. QA,R&D)  

The Essenvia RIM Platform allows you to easily manage change assessment and streamline collaboration between regulatory and other departments (e.g. QA,R&D)  

The Essenvia RIM Platform allows you to easily manage change assessment and streamline collaboration between regulatory and other departments (e.g. QA,R&D)  

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 the impact of changes on existing devices?

How can the Essenvia RIM Platform help you manage the impact of changes on existing devices?

How can the Essenvia RIM Platform help you manage the impact of changes on existing devices?

Change Assessment Automation

Native integration with PLM/ eQMS
to automate change assessment.

Native integration with PLM/ eQMS
to automate change assessment.

Regulatory Intelligence

Regulatory intelligence to determine the impact of change
(significant or insignificant change).

Regulatory intelligence to determine the impact of change
(significant or insignificant change).

Faster Letter-to-file / Memo-to-file

Automate creation of letter to file/memo to file.


Automate creation of letter to file/memo to file.


Project Management Made Easy

Project management across changes
from initial assessment to closure.

Project management across changes
from initial assessment to closure.

Change Assessement in Medical Devices: Understanding Regulatory Implications

Change Assessement in Medical Devices: Understanding Regulatory Implications

Change Assessement in Medical Devices: Understanding Regulatory Implications

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!