step 1
Managing Your Medical Device Regulatory Strategy
One central location where you can manage your entire regulatory strategy. Any changes you make here will cascade throughout the rest of your document.
step 1
Managing Your Medical Device Regulatory Strategy
One central location where you can manage your entire regulatory strategy. Any changes you make here will cascade throughout the rest of your document.
step 2
Preparing Your Regulatory Submission
Use our application builder program to quickly create an accurate and error-free regulatory submission – including both 510k and MDR for CE Mark.
step 3
Automating The Submission Process
Once you collect the content, you have to spend hours formatting it according to regulatory standards. Our solution takes all of this information and formats your entire application in just one click.
step 3
Automating The Submission Process
Once you collect the content, you have to spend hours formatting it according to regulatory standards. Our solution takes all of this information and formats your entire application in just one click.
step 4
Maintaining The Post Market Requirements
Once your medical device enters the market, easily manage your post market regulatory requirements. Use easy questions and answers to assess significance of regulatory impact due to changes in technology, labeling, software etc. and determine a letter to file vs New submission. In-built templates simplify the whole process to build and manage post-market reporting requirements.
Essenvia is built by medical device regulatory experts to help medical device regulatory teams scale regulatory operations.
Essenvia helps regulatory professionals turn regulatory operations into a strategic competitive advantage by providing up to date regulatory templates, submission automation, integrated online collaboration, and one-click publishing. A unified solution to support regulatory teams of all sizes for managing regulatory processes across the entire lifecycle of their medical devices.
Our Investors
The Essenvia Solution
Our platform is a one-of-a-kind solution to support your team and device throughout the entire regulatory lifecycle.
We understand you may have several questions about how we can help you specifically.
Therefore, we offer a no-obligation consultation to anyone who is interested in learning more about how we can help make your job easier.
