Accelerate the
transition to EUMDR/IVDR
Streamline your MDR submissions with the help
of reusable content, pre-built templates
and collaborative content authoring.
Accelerate the
transition to EUMDR/IVDR
Streamline your MDR submissions with the help
of reusable content, pre-built templates
and collaborative content authoring.
Accelerate the
transition to EUMDR/IVDR
Streamline your MDR submissions with the help
of reusable content, pre-built templates
and collaborative content authoring.
Accelerate the
transition to EUMDR/IVDR
Streamline your MDR submissions with the help
of reusable content, pre-built templates
and collaborative content authoring.
TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE
TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE
TRUSTED BY INNOVATIVE MEDTECH COMPANIES WORLDWIDE
TRUSTED BY INNOVATIVE
MEDTECH COMPANIES WORLDWIDE
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.
Easy to implement and to integrate with your QMS, CRM, or PLM.
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.
"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 it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."
"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 it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."
"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 it into the FDA’s eSTAR file, and immediately submit the same file successfully through the FDA’s Customer Collaboration Portal (CCP)."
MARTA STEPIEN
MARTA STEPIEN
MARTA STEPIEN
VP of Clinical, Regulatory and Quality Affairs
VP of Clinical, Regulatory and Quality Affairs
Save 4+ weeks per
MDR Submission
Send file requests to your collaborators letting them upload and share technical files directly into your project:
Continuous deadline reminders
Self-healing appendices update when files change
Files auto-convert to compatible formats
Files available for multiple MDR/IVDR submissions
Manage access on account, submission, line levels
Save 4+ weeks per
MDR Submission
Send file requests to your collaborators letting them upload and share technical files directly into your project:
Continuous deadline reminders
Self-healing appendices update when files change
Files auto-convert to compatible formats
Files available for multiple MDR/IVDR submissions
Manage access on account, submission, line levels
Save 4+ weeks per
MDR Submission
Send file requests to your collaborators letting them upload and share technical files directly into your project:
Continuous deadline reminders
Self-healing appendices update when files change
Files auto-convert to compatible formats
Files available for multiple MDR/IVDR submissions
Manage access on account, submission, line levels
Save 4+ weeks per
MDR Submission
Send file requests to your collaborators letting them upload and share technical files directly into your project:
Continuous deadline reminders
Self-healing appendices update when files change
Files auto-convert to compatible formats
Files available for multiple MDR/IVDR submissions
Manage access on account, submission, line levels
Compose, Collaborate &
Track Simultaneously
Co-author MDR/IVDR submissions directly inside of the submission file:
Eliminate manual status trackers and checklists
Reduce content sprawl across multiple repositories
Eliminate redundant content and attachments
Co-author directly inside of each submission
Compose, Collaborate &
Track Simultaneously
Co-author MDR/IVDR submissions directly inside of the submission file:
Eliminate manual status trackers and checklists
Reduce content sprawl across multiple repositories
Eliminate redundant content and attachments
Co-author directly inside of each submission
Compose, Collaborate &
Track Simultaneously
Co-author MDR/IVDR submissions directly inside of the submission file:
Eliminate manual status trackers and checklists
Reduce content sprawl across multiple repositories
Eliminate redundant content and attachments
Co-author directly inside of each submission
Compose, Collaborate &
Track Simultaneously
Co-author MDR/IVDR submissions directly inside of the submission file:
Eliminate manual status trackers and checklists
Reduce content sprawl across multiple repositories
Eliminate redundant content and attachments
Co-author directly inside of each submission
100% Assurance
Essenvia’s submission templates
have a 100% acceptance rate
100% Assurance
Essenvia’s submission templates
have a 100% acceptance rate
100% Assurance
Essenvia’s submission templates
have a 100% acceptance rate
EUMDR/IVDR Faster
with Re-Usable Data
Go faster after your first submission, by storing and re-using master information in new MDR/IVDR submissions:
Company information
Device information
Regulatory information
Other data and technical files
EUMDR/IVDR Faster
with Re-Usable Data
Go faster after your first submission, by storing and re-using master information in new MDR/IVDR submissions:
Company information
Device information
Regulatory information
Other data and technical files
EUMDR/IVDR Faster
with Re-Usable Data
Go faster after your first submission, by storing and re-using master information in new MDR/IVDR submissions:
Company information
Device information
Regulatory information
Other data and technical files
EUMDR/IVDR Faster
with Re-Usable Data
Go faster after your first submission, by storing and re-using master information in new MDR/IVDR submissions:
Company information
Device information
Regulatory information
Other data and technical files
Get Regulatory Alerts
Put research on autopilot with regulatory alerts directly from regulatory authority data feeds, including:
Recalls
New or existing competitors
Multiple indications
Get Regulatory Alerts
Put research on autopilot with regulatory alerts directly from regulatory authority data feeds, including:
Recalls
New or existing competitors
Multiple indications
Get Regulatory Alerts
Put research on autopilot with regulatory alerts directly from regulatory authority data feeds, including:
Recalls
New or existing competitors
Multiple indications
Get Regulatory Alerts
Put research on autopilot with regulatory alerts directly from regulatory authority data feeds, including:
Recalls
New or existing competitors
Multiple indications
Zero Implementation. Start Today.
Essenvia requires no technical implementation, which means you could be starting your submission in minutes:
No integrations required
MDR/IVDR ready with one click
No training to get started
No IT implementation
Zero Implementation. Start Today.
Essenvia requires no technical implementation, which means you could be starting your submission in minutes:
No integrations required
MDR/IVDR ready with one click
No training to get started
No IT implementation
Zero Implementation. Start Today.
Essenvia requires no technical implementation, which means you could be starting your submission in minutes:
No integrations required
MDR/IVDR ready with one click
No training to get started
No IT implementation
Zero Implementation. Start Today.
Essenvia requires no technical implementation, which means you could be starting your submission in minutes:
No integrations required
MDR/IVDR ready with one click
No training to get started
No IT implementation
Re-use FDA data in new MDR submissions
Re-use US FDA submission data in new MDR/IVDR submissions with intelligent mapping across:
Company information
Device information
Regulatory information
Other data and technical files
Re-use FDA data in new MDR submissions
Re-use US FDA submission data in new MDR/IVDR submissions with intelligent mapping across:
Company information
Device information
Regulatory information
Other data and technical files
Re-use FDA data in new MDR submissions
Re-use US FDA submission data in new MDR/IVDR submissions with intelligent mapping across:
Company information
Device information
Regulatory information
Other data and technical files
Re-use FDA data in new MDR submissions
Re-use US FDA submission data in new MDR/IVDR submissions with intelligent mapping across:
Company information
Device information
Regulatory information
Other data and technical files