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

Meet the Industry's Only Agentic AI RIMS
Built for MedTech Regulatory Teams

Meet the Industry's Only Agentic AI RIMS Built for MedTech Regulatory Teams

Don't just centralize registrations, automate Submissions (including FDA eSTAR), gain AI-driven

Regulatory Intelligence, Regulatory Strategy, and Search and Report — all in one platform.

Book a Demo

See a Video

Fast & Secure Setup

Draft in Hours

Stay Ahead of Changes

Track Everything

Fast & Secure Setup

Draft in Hours

Manage Changes

Track Everything

Fast & Secure Setup

Draft in Hours

Manage Changes

Track Everything

Partnering with

Security Certifications

Decrease submission cycle time by 3 months

<

90

Days to Launch

From data ingestion to user login in < 90 days.

70 %

Faster Submissions

AI generates 66% of submissions documents

80 +

Countries Monitored

Stay ahead of regulatory changes in real-time.

100 %

Data Visibility

Single source of truth for all of your regulatory data.

The world’s leading medtech enterprises transform Regulatory Affairs work with Essenvia RIMS AI.

Trusted By

Essenvia RIMS AI Core Features

Connect, Migrate,

& Enrich Your Data

SSO integration with your existing systems. SOC2 compliant AI-powered migration and enrichment verified health authority datasources.

<

90

Days to
Launch

Explore

Connect, Migrate,

& Enrich Your Data

SSO integration with your existing systems. SOC2 compliant AI-powered migration and enrichment verified health authority datasources.

<

90

Days to
Launch

Explore

Submission AI+

Patented eSTAR Portal

Essenvia AI accelerates Global Submission Generation

+

70 %

Faster
Submissions

Explore

Submission AI+

Patented eSTAR Portal

Essenvia AI accelerates Global Submission Generation

+

70 %

Faster
Submissions

Explore

Regulatory

Intelligence

Monitor and keep up with rapidly evolving global regulations across your portfolio

80 +

Countries
Mentioned

Explore

Your Single

Source of Truth

Complete storage and lifecycle tracking for submissions, registrations, and products with connections that power automation

and impact analysis

100 %

Data
Visibility

Explore

Your Single

Source of Truth

Complete storage and lifecycle tracking for submissions, registrations, and products with connections that power automation

and impact analysis

100 %

Data
Visibility

Explore

Trusted by Regulatory Affairs Teams globally

“Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without the platform”
JOHN LANSDOWN
Director of Quality, Regulatory & Compliance
"The ability to have users manage specific eSTAR sections is really cool"
Manager Regulatory Affairs
Top 30 Medtech
"I've seen a lot of so called AI softwares but very few are actually AI, and this [Essenvia] is the real deal"
Regulatory VP
Top 15 Medtech

“Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits an even major updates at the last minute for very complex submissions. We can’t live without the platform”
JOHN LANSDOWN
Director of Quality, Regulatory & Compliance
"The ability to have users manage specific eSTAR sections is really cool"
Manager Regulatory Affairs
Top 30 Medtech
"I've seen a lot of so called AI softwares but very few are actually AI, and this [Essenvia] is the real deal"
Regulatory VP
Top 15 Medtech

"Super user friendly, and I really like the modular approach"
Manager Regulatory Affairs
Top 40 Medtech
“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”
SEJAL CHITRE
Director Global Regulatory Affairs
"Essenvia’s collaborative eSTAR solution reduces a critical friction in submissions authoring and publishing. We're focused on optimizing big ticket submissions that involve multiple people"
Director Regulatory Affairs
Top 30 Medtech

"Super user friendly, and I really like the modular approach"
Manager Regulatory Affairs
Top 40 Medtech
“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”
SEJAL CHITRE
Director Global Regulatory Affairs
"Essenvia’s collaborative eSTAR solution reduces a critical friction in submissions authoring and publishing. We're focused on optimizing big ticket submissions that involve multiple people"
Director Regulatory Affairs
Top 30 Medtech

"The platform reduced our manual effort for submissions in Brazil and Mexico by 70%, freeing our time for strategic work. It is so easy and intuitive to use."
Sr. RA Specialist
Top 3 Medtech
"We're evaluating tools that have the potential to decrease manual work and increase productivity and margins - and this platform clearly demonstrated its potential to achieve that."
Sr. Director, Global Reg Submissions
Top 5 Medtech
“We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to this Platform 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 it’s being prepared and completed.

Once the submission was ready in the Essenvia Platform, we were able to instantly publish into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)”
MARTA STEPIEN
VP of clinical, Regulatory and Quality Affairs

"The platform reduced our manual effort for submissions in Brazil and Mexico by 70%, freeing our time for strategic work. It is so easy and intuitive to use."
Sr. RA Specialist
Top 3 Medtech
"We're evaluating tools that have the potential to decrease manual work and increase productivity and margins - and this platform clearly demonstrated its potential to achieve that."
Sr. Director, Global Reg Submissions
Top 5 Medtech
“We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to this Platform 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 it’s being prepared and completed.

Once the submission was ready in the Essenvia Platform, we were able to instantly publish into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)”
MARTA STEPIEN
VP of clinical, Regulatory and Quality Affairs

Media Hub

RIM Implementation

Oct 23, 2025

An AI-Powered RIMS Solution that Works: Lessons from Terumo's Rollout

Discover the proven 7-step playbook that helped Terumo Medical Corporation launch their AI-powered RIMS in under 90 days—and learn why 95% of AI implementations fail while theirs succeeded. Featuring insights from RAPS Convergence 2025.

Essenvia & MedTech Summit

Jun 26, 2024

Digital Transformation in MedTech Reg Affairs: A "Must" or a "Nice to Have"?

MedTech transformation & how it connects to digital transformation is explored in this presentation from the 2024 MedTech Summit. Viewers will gain insight into top digital priorities that medical device leaders are actively pursuing & the myriad challenges professionals face.

FDA & EU

Jan 25, 2024

The impact of modern Regulatory (RIM) technology on time to market

Different policies and submission procedures across countries and regions create a significant barrier to meeting regulatory deadlines and can easily become an intricate puzzle if there is not a centralized Regulatory (RIM) Platform to merge and automate all regulatory processes and data.

Learn more about the Essenvia RIM Platform

Contact us for a Demo

Book a Demo

Meet the Industry's Only Agentic AI RIMS Built for MedTech Regulatory Teams

Meet the Industry's Only Agentic AI RIMS Built for MedTech Regulatory Teams

Meet the Industry's Only Agentic AI RIMS Built for MedTech Regulatory Teams

Partnering with

Security Certifications

Decrease submission cycle time by 3 months

Decrease submission cycle time by 3 months

<

<

90

Days to Launch

70

%

Faster Submissions

80

+

Countries Monitored

100

%

Data Visibility

The world’s leading medtech enterprises transform Regulatory Affairs work with Essenvia RIMS AI.

The world’s leading medtech enterprises transform Regulatory Affairs work with Essenvia RIMS AI.

Essenvia RIMS AI Core Features

Essenvia RIMS AI Core Features

Connect, Migrate,

& Enrich Your Data

<

90

Days to Launch

Connect, Migrate,

& Enrich Your Data

<

90

Days to Launch

Submission AI+

Patented eSTAR Portal

+

70

%

FasterSubmissions

Submission AI+

Patented eSTAR Portal

+

70

%

FasterSubmissions

Regulatory

Intelligence

80

+

CountriesMentioned

Your Single

Source of Truth

100

%

Data Visibility

Your Single

Source of Truth

100

%

Data Visibility

Trusted by Regulatory Affairs Teams globally

Trusted by Regulatory Affairs Teams globally

Media Hub

Media Hub

An AI-Powered RIMS Solution that Works: Lessons from Terumo's Rollout

An AI-Powered RIMS Solution that Works: Lessons from Terumo's Rollout

An AI-Powered RIMS Solution that Works: Lessons from Terumo's Rollout

An AI-Powered RIMS Solution that Works: Lessons from Terumo's Rollout

Digital Transformation in MedTech Reg Affairs: A "Must" or a "Nice to Have"?

Digital Transformation in MedTech Reg Affairs: A "Must" or a "Nice to Have"?

Digital Transformation in MedTech Reg Affairs: A "Must" or a "Nice to Have"?

Digital Transformation in MedTech Reg Affairs: A "Must" or a "Nice to Have"?

The impact of modern Regulatory (RIM) technology on time to market

Learn more about the Essenvia RIM Platform

Contact us for a Demo

Contact us for a Demo

Meet the Industry's Only Agentic AI RIMS
Built for MedTech Regulatory Teams

Days to
Launch

Days to
Launch

Faster
Submissions

Faster
Submissions

Countries
Mentioned

Data
Visibility

Data
Visibility