A Faster Way to Submit Technical Files From Your Class I Device

If you have created submitted a Technical file before, you know how complex 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 completing a rejection proof document.

Essenvia has worked with countless industry experts to gain a deep understanding of how difficult and tedious this process is. Our application builder is essentially a brain dump from veterans in this space with decades of experience in creating and submitting technical files. It is developed from the inputs of experts with 20+ years of experience including several who use it for all of their MDR regulatory submissions.

We have developed a program that will help you complete your Technical File application on time, under budget, and free of the most common errors that lead to rejection. 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 Technical File documentation 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 but it helps you spend less time on formatting and more time on content.

The Latest MDR Templates and Requirements

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

Your application will never get rejected for using out-of-date templates or incorrect wording. You can finally enjoy the peace of mind knowing your application only includes completely vetted and MDR 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 process 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 20% complete.

NOTE: If you use our app builder to create your 510(k) you can transfer information, files and content into your new technical file. This saves a considerable amount of time and work and helps you submit your file faster.

No More Worrying About Critical Changes

No matter what, you are going to have all types of critical information change and be revised throughout this application 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 once, 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 files and attachments 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

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 are 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 this 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 100 of hours collecting, collating and formatting your Technical File.

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 everyday.

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 Class I Technical File Builder was designed for three things:

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

Error Preventing Solutions

Our software is fully integrated with the EU 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 MDR compliant without having to waste hours doing unnecessary administrative work.

Simplifying The GSPR Compliance Checklist

The GSPR Checklist must be included in your MDR Technical Files. It often times will sneak up on you right when you think you are done. This exhausting section includes 100 questions regarding the content you just spent hours putting together.

Our program will help you easily search, add applicable standards and associated evidence to determine which questions are relevant and which can be skipped.

One-Click and Submission Ready

No more fighting with Adobe to get the formatting guidelines to work or worry about. Once your application is built, you can instantly output it in the correct 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 FDA Cleatance? Switch To Our 510(k) Builder

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

Class I MDR Technical File Builder is part of Essenvia – a suite of software solutions 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