Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

Available Now: Complimentary eSTAR Office Hours with our experts

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.

Essenvia EUMDR submission previews with one click
Essenvia EUMDR submission previews with one click
Essenvia EUMDR submission previews with one click
Essenvia EUMDR submission previews with one click

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

See all open requests to review submissions on Essenvia
See all open requests to review submissions on Essenvia
See all open requests to review submissions on Essenvia
See all open requests to review submissions on Essenvia
Queue up file requests ahead of submission time to have the technical files come to you - Essenvia
Queue up file requests ahead of submission time to have the technical files come to you - Essenvia
Queue up file requests ahead of submission time to have the technical files come to you - Essenvia
Queue up file requests ahead of submission time to have the technical files come to you - Essenvia

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

Master data library can map the same dataset into multiple regulatory submissions saving you valuable time only on Essenvia
Master data library can map the same dataset into multiple regulatory submissions saving you valuable time only on Essenvia
Master data library can map the same dataset into multiple regulatory submissions saving you valuable time only on Essenvia
Regulatory intelligence comes to your inbox with intelligent alerts directly from regulatory authortiy data feeds only on essenvia
Regulatory intelligence comes to your inbox with intelligent alerts directly from regulatory authortiy data feeds only on essenvia
Regulatory intelligence comes to your inbox with intelligent alerts directly from regulatory authortiy data feeds only on essenvia
Regulatory intelligence comes to your inbox with intelligent alerts directly from regulatory authortiy data feeds only on essenvia

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

Your MedTech regulatory submission is ready on Essenvia
Your MedTech regulatory submission is ready on Essenvia
Re-use EUMDR regulatory submission data in US FDA 510k eSTAR submissions only on Essenvia
Re-use EUMDR regulatory submission data in US FDA 510k eSTAR submissions only on Essenvia
Re-use EUMDR regulatory submission data in US FDA 510k eSTAR submissions only on Essenvia
Re-use EUMDR regulatory submission data in US FDA 510k eSTAR submissions only on Essenvia

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