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

Consolidate your Regulatory Activities into One Centralized Platform

Consolidate your Regulatory Activities into One Centralized Platform

Consolidate your Regulatory Activities into One Centralized Platform

Consolidate your Regulatory Activities into One Centralized Platform

Essenvia leverages AI to make it easy to manage registrations, submissions, changes, and communication with health authorities, allowing your regulatory specialists to concentrate on high-value activities.

Essenvia leverages AI to make it easy to manage registrations, submissions, changes, and communication with health authorities, allowing your regulatory specialists to concentrate on high-value activities.

Essenvia leverages AI to make it easy to manage registrations, submissions, changes, and communication with health authorities, allowing your regulatory specialists to concentrate on high-value activities.

See it in Action

See it in Action

Contact Us

Contact Us

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE
MEDTECH COMPANIES WORLDWIDE

TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE

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.

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.

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.

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

All-in-One Platform

AI-powered

Registrations
Management

Registrations
Management

Registrations
Management

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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

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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

Instantly generate final submission files with 1-Click

AI-powered

Change
Management

Change
Management

Change
Management

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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

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

5 eSTAR Challenges MedTech Regulatory Teams Must Overcome

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Read Other Resources

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!

Get a Demo

Get a Demo