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 4

Maintaining The Post Market Requirements

Once your medical device enters the market, we are here to help you manage your next steps. We will help you through the regulatory change assessment to determine whether or not the changes you made to your device like technology, labeling, materials and software requires a new submission. We will also help you manage your post-market reporting requirement.

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.

Let’s Talk