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

Pricing

Get the best value for your unique regulatory needs and specific requirements

Essenvia RIM Platform offers a scalable pricing model based on an annual subscription.

Pricing

Get the best value for your unique regulatory needs and specific requirements

Essenvia RIM Platform offers a scalable pricing model based on an annual subscription.

Pricing

Get the best value for your unique regulatory needs and specific requirements

Essenvia RIM Platform offers a scalable pricing model based on an annual subscription.

Pricing

Get the best value for your unique regulatory needs and specific requirements

Essenvia RIM Platform offers a scalable pricing model based on an annual subscription.

Regulatory submission review requests on Essenvia

Regulatory submission review requests on Essenvia

Regulatory submission review requests on Essenvia

Regulatory submission review requests on Essenvia

Why Choose the
Essenvia RIM Platform?

Why Choose the
Essenvia RIM Platform?

Why Choose the
Essenvia RIM Platform?

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

Consolidate your regulatory activities into one centralized platform and bring your devices to market faster.

Our seasoned RA team will configure the platform
to adapt to your own regulatory templates and workflows.

Incredibly easy to use. Start realizing efficiency gains in the first weeks of usage.

A Complete Regulatory Platform for MedTech Companies

A Complete Regulatory Platform for MedTech Companies

AI-powered

Registrations
Management

Registrations
Management

Registrations
Management

Get a demo

Features include:

Manage SKU-level product registration lifecycle by country

Central repository for all registration docs linked to product master data

Dashboard with ability to track global registration status

Alerts and notifications

Integration to ERP/PLM for data and document sync

AI-powered

Submissions
Management

Submissions
Management

Submissions
Management

Get a demo

Features include:

Extensive templates library compliant with all regulations and countries

Reusable content automation across submissions

PLM/eQMS integration to automate submissions

FDA eSTAR collaborative authoring (unique)

Instantly generate final submission files with 1-Click

AI-powered

Change
Management

Change
Management

Change
Management

Get a demo

Features include:

Automate Regulatory Change assessment

Determine impact of change (significant or insignificant)

Automate creation of Letter to file / memo to file

Project management across changes from initial assessment to closure