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.
- Company logo of Vios
- Company logo of Sleepiz
- Company logo of Vios
- Company logo of Sleepiz
- Company logo of Vios
- Company logo of Sleepiz
- Company logo of Vios
- Company logo of Sleepiz
Why
Essenvia?
Zero Implementation
Start using Essenvia today and realize benefits in the first week
Faster Submissions
Save up to 4 weeks per submission and get your medical devices to market faster
100% Assurance
Essenvia has been used in more than 300 submissions with a 100% acceptance rate
Why
Essenvia?
Zero Implementation
Start using Essenvia today and realize benefits in the first week
Faster Submissions
Save up to 4 weeks per submission and get your medical devices to market faster
100% Assurance
Essenvia has been used in more than 300 submissions with a 100% acceptance rate
Why
Essenvia?
Zero Implementation
Start using Essenvia today and realize benefits in the first week
Faster Submissions
Save up to 4 weeks per submission and get your medical devices to market faster
100% Assurance
Essenvia has been used in more than 300 submissions with a 100% acceptance rate
Why
Essenvia?
Zero Implementation
Start using Essenvia today and realize benefits in the first week
Faster Submissions
Save up to 4 weeks per submission and get your medical devices to market faster
100% Assurance
Essenvia has been used in more than 300 submissions with a 100% acceptance rate
"Thanks to Essenvia, writing the technical files became much easier and we achieved faster clearance in both the UK and the EU. We are highly impressed with this platform”
"Thanks to Essenvia, writing the technical files became much easier and we achieved faster clearance in both the UK and the EU. We are highly impressed with this platform”
"Thanks to Essenvia, writing the technical files became much easier and we achieved faster clearance in both the UK and the EU. We are highly impressed with this platform”
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 with the US and EU regulatory bodies
100% Assurance
Essenvia’s submission templates have a 100% acceptance rate with the US and EU regulatory bodies
100% Assurance
Essenvia’s submission templates have a 100% acceptance rate with the US and EU regulatory bodies
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