A Faster, More Efficient Way To Submit Your 510(k)

If you have submitted a 510(k) before, you know how complex, tedious, and time-consuming it can be. If this is your first time, you may have very little idea of the pain that awaits you when it comes to formatting, gathering information, and submitting a rejection proof document to the FDA.

Essenvia has worked with countless industry experts just like yourself to gain a deep understanding of how difficult and tedious this process is. This program is essentially a brain dump from several mentors and FDA veterans with decades of submission experience. It is developed from the inputs of experts with 20+ years of experience including several who use it for all of their regulatory submissions.

We have developed a program that will help you complete your 510(k) application on-time, under budget, and free of the most common errors that lead to rejection by the FDA. Together, we can get you spending less time on formatting your application and more time compiling the content inside of it.

Finally, a tool that understands my pain and provides real solutions!

Only those who have been put in charge of a 510(k) application submission before truly understand the type of formatting hell and information collecting purgatory that you go through.

This includes spending nearly 40 hours of your already busy schedule to perform tedious administrative work when you could be using your skills towards more important and impactful deliverables.

Essenvia understands this pain because we built our program to directly solve these types of problems. Not only does our software replace Microsoft Word, Excel, and Adobe, it helps you spend less time on formatting and more time on content.

The Latest FDA Templates and Requirements

No more wasting time figuring out if you are using the most up-to-date FDA templates. Our software will always provide you with the latest templates that the FDA requires.

Your application will never get rejected for using out-of-date templates or incorrect wording. You can enjoy the peace of mind knowing you are only using completely vetted and FDA approved templates.

Stop Typing In The Same Information Over and Over

Who has time to type in the same data over and over again? This type of manual data entry can only lead to errors. Our advanced autofill feature captures key information and then automatically cascades it through the rest of your application.

Your application will require you to enter in your Intended Use Statement over 20 times alone. Imagine filling in information one time and within minutes your application is up to 30% complete.

No More Worrying About Critical Changes

No matter what, you are going to have some type of critical information change throughout this process. It’s a huge pain to then have to scan your entire application to find every place this change impacts.

Our Changelock™️ is the fanciest “find and replace” you’ve ever seen. Once you make that critical change, you can move on knowing it’s been changed throughout your entire application.

No More Microsoft Word Formatting Issues

Yes, things like page numbers, table of contents, headers, and footers are important. However, you don’t have time to struggle with Microsoft Word, PDF Editor, Excel or any of the other programs this type of application requires.
You also need a program that doesn’t give you a headache when it comes to uploading necessary PDFs and images or swapping out outdated PDFs for new ones. We built a solution to help take care of all of this for you.

We Work With The Apps You Are Already Using

We understand that the documents and information you need are either already stored somewhere or will be supplied to you by someone else.

Either way, we have you covered by ensuring our app integrates with Dropbox, Box, and Sharepoint file systems. It is just one more way we add efficiency and organization to process with many moving parts.

Get Back To What You Are Meant To Be Doing

Let’s face it, you are way too talented to be spending over 40 hours formatting a 510(k) submission. Your skills should be put to much better use than these types of administrative tasks.

There are countless tasks, projects, and deliverables you could be working on instead. Our program gives you back this time and in turn, helps your company achieve more daily.

Your data is your own. We keep it safe and secure.

Our Success Stories

“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, CTO, 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.

“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 makes your life easier by organizing, paginating and formatting your documentation package per e-Copy guidelines. As a cloud-based system, Essenvia allows the owner to control and work with associates around the world while using your own pre-defined templates. From personal experience this is a one of a kind productivity tool."

– Frank Pokrop, Director Regulatory Affairs

Get As Close To A Rejection Proof Application As Possible

Our 510(k) Application Builder was designed for three things:

1. Expedite the submission process
2. Prepare an error-proof and FDA compliant application
3. Help you avoid wasting time and making common submission mistakes

Error Preventing Solutions

Our software is fully integrated with the FDA database to provide the most up-to-date documents and templates. Our Autofill and Changelock™ features ensure accuracy and consistency throughout your entire application. This means your application will be FDA compliant without having to waste hours doing unnecessary administrative work.

Simplifying The RTA Compliance Checklist

The RTA Compliance Checklist will often times sneak up on you right when you think you are done. This exhausting section includes 56 questions regarding the content you just spent hours putting together.

Our tool will help you determine which questions are relevant to your device and which can be skipped. We also provide a function that allows you to complete these questions at the same time you complete the section.

Automatically eCopy Ready

No more fighting with Adobe to get the FDA eCopy module to work or worrying about completing this task on your Mac. Once your application is built, you can instantly output it in the FDA eCopy format.

That means Essenvia takes care of formatting your table of contents, page numbers, and section formatting with the press of a button. 

Looking for clearance in the EU? Try Our Tech File Builder

Managing Regulation is hard, assembling applications doesn’t have to be.

510(k) Application Builder is part of Essenvia – a suite of software services designed to help regulatory affairs specialists like you streamline and automate your pre and post-market activities with ease.

Want to learn more? Contact Us