Essenvia is your regulatory lifecycle expert and mentor.

Our solutions include an innovative approach to building both your 510(k) and MDR submissions. Our software is designed to reduce errors, streamline processes, and guarantee faster regulatory clearance for your medical device.

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Benefits

A Single Source of Truth

Everything you need in one place – Easily locate key information including product codes, guidance documents, and regulatory body approved templates.

Seamless Integration of
Key Documents

Ensure you always include the latest documents, tables, and charts by allowing your teams to upload files straight into your application.

Smart Forms and Templates

Say goodbye to entering the same information over and over again. With our smart templates, enter in key information once and it cascades into every applicable section.

Accelerate Time To Market

Significantly reduce the amount of time it takes to complete your application by eliminating time-wasters such as administrative errors, retyping information, numbering tables, and formatting issues.

Produce An Accurate Submission

More than 30% of applications are rejected by regulatory agencies due to discrepancies, inaccuracies, or omissions. Our application builder contains several safeguards to deliver an accurate and error-free submission.

Testimonials

I may be the single strongest advocate of the Essenvia platform.

Why? Because, as a regulatory consultant, the more efficient I am, the more clients I can take, the more I can earn.

Essenvia gives me up-to-date templates, easy dropdowns, and pre-populates fields to ensure consistency.

If you need regulatory clearance, you’d be foolish not to use Essenvia (or hire someone like me who does!)

– Michelle Lott, RAC

Founder and Principal
leanRAQA

“For regulatory professionals, the Essenvia software platform is long overdue and it will streamline your submission efforts.

By managing 510(k)’s, pre-sub materials and EU technical files, Essenvia seamlessly organized, paginates, and formats your documentation package per e-Copy guidelines.

As a cloud-based system, Essenvia allows you to share your own pre-defined templates with associates around the world.

From my personal experience, this is a one of a kind productivity tool I strongly endorse.”

– Frank Pokrop

Dir. Reg. Affairs And Quality Assurance

“I was totally new to the 510(k) process prior to Essenvia, and the software has been a big help to build the project, but I would say the biggest advantage is the support!

The team at Essenvia guided me through the whole process and provided more insight than I could have hoped for.”

– Robert Futch

Chief Technology Officer
Delta Development Inc.

“Our 510(k) submission included a large number of supporting documents; managing, embedding and adding headers, footers and page numbers to these files would have been a nightmare without Essenvia.

Given our large number of supporting documents, their built-in reference and linking features were extremely helpful and saved me a lot of time by not having to manually cross-reference items.”

– Lynsie Thomason

Director of Product Management
Innovere Medical Inc.

“Using this innovative web-based platform for complex FDA submissions is a transformative experience for me, a former FDA reviewer, now Regulatory Consultant.

The Essenvia workspace masterfully integrates and interconnects the many sections of a regulatory submission. The multi-user interactivity feature provides a robust way to track completion of user assignments.”

– Stuart Portnoy, MD

Principal Consultant
Prism Medical Device Consulting