Your Regulatory
Lifecycle Partner

The regulatory life cycle for your medical device is both arduous and never-ending. Wouldn’t it be nice if you had a platform, built by the experts, to provide support and guidance?

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

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.

Essenvia is built by medical device experts to help regulatory specialists transform medical device regulatory affairs operations.

Essenvia helps regulatory professionals turn regulatory operations into a strategic competitive advantage by providing research, document automation, collaboration, and project management. Essenvia’s platform offers regulatory teams of all sizes a unified solution for managing regulatory processes across the entire lifecycle of their medical devices.

Meet Our Team