MedTech companies
trust Essenvia to achieve Regulatory Excellence
Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.
MedTech companies
trust Essenvia to achieve Regulatory Excellence
Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.
MedTech companies
trust Essenvia to achieve Regulatory Excellence
Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.
MedTech companies
trust Essenvia to achieve Regulatory Excellence
Since 2018, the Essenvia RIM Platform has been helping MedTech companies worldwide in efficiently managing regulatory workflows.
350+
Submissions prepared with
the Essenvia RIM Platform
350+
Submissions prepared with the Essenvia RIM Platform
350+
Submissions prepared with
the Essenvia RIM Platform
350+
Submissions prepared with
the Essenvia RIM Platform
100+
New medical devices
brought to market
100+
New medical devices brought to market
100+
New medical devices
brought to market
100+
New medical devices
brought to market
100%
Submission
acceptance rate
100%
Submission acceptance rate
100%
Submission
acceptance rate
100%
Submission
acceptance rate
Essenvia Customer for 3+ Years
“
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits, and even major updates at the last minute for very complex submissions. We can’t live without the platform.”
Essenvia greatly shortens the time to submission. It saved us countless hours in managing files, edits, and even major updates at the last minute for very complex submissions. We can’t live without the platform.”
John Landsdown
Director of Quality, Regulatory, and Compliance
Essenvia Customer for 2+ Years
“
With the help of the Essenvia Platform, we have successfully obtained clearance both in the UK and in the EU! Essenvia has truly been instrumental in our success, and we are grateful for your continued support.”
With the help of the Essenvia Platform, we have successfully obtained clearance both in the UK and in the EU! Essenvia has truly been instrumental in our success, and we are grateful for your continued support.”
VP of Clinical, Regulatory, and Quality Affairs
A global publicly traded In Vitro Diagnostics company
Navigate the complex world of regulatory compliance with confidence.
Essenvia Customer for 3+ Years
“
We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to Essenvia, 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 they´re being prepared and completed.”
We completed and successfully submitted our first FDA eSTAR submission using Essenvia. Thanks to Essenvia, 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 they´re being prepared and completed.”
Marta Stepien
VP of Clinical, Regulatory, and Quality Affairs
Essenvia Customer for 2+ Years
“
Essenvia's PMA automation tool has revolutionized our regulatory affairs operations. By streamlining administrative tasks and enhancing data visibility, we saved time and improved accuracy. The eSTAR and RIM systems ensure 100% submission accuracy and project tracking, while the submission edit features expedite processes and facilitate collaboration. They provided exceptional customer service, and the Essenvia technology exceeded our expectations, proving to be an invaluable asset to our company.”
Essenvia's PMA automation tool has revolutionized our regulatory affairs operations. By streamlining administrative tasks and enhancing data visibility, we saved time and improved accuracy. The eSTAR and RIM systems ensure 100% submission accuracy and project tracking, while the submission edit features expedite processes and facilitate collaboration. They provided exceptional customer service, and the Essenvia technology exceeded our expectations, proving to be an invaluable asset to our company.”
VP of Clinical and Regulatory Affairs
A global leader in the preservation and perfusion of organs
Accelerate global market access, reduce costs, and focus on what your company does best: Innovation!