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.
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!)
“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.”
“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.”
“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.”
“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.”
FAQ
In simple terms, we help companies get medical devices to market faster by streamlining the 510(k) applications, MDR submissions, Letters to File, and related regulatory application processes.
We consulted with regulatory specialists and industry experts to understand the most common pain points when preparing submissions. Then, we developed a product to solve them.
We work with anyone trying to get their medical device cleared in an efficient and timely manner.
Individuals who have years of experience compiling 510(k) applications and MDR submissions and submitting them for clearance.
If those years have been an enjoyable experience, then you shouldn’t. However, if you have wasted hours completing tedious tasks and making changes, then you may want to give our product a try.
This one's easy. Your boss wants to get to market as fast as possible, confident everything is done perfectly. That's our reason for being: Giving you a time-saving structure to ensure accuracy and speed.
Yes, we provide a detailed knowledge base for your users.
We offer a free trial which can be accessed at this link. To unlock all features, please contact us.
Yes. In fact, your account stays active unless you instruct us otherwise. You may use your free trial as long as you like.
Of course. For data, privacy, and integrity, we are compliant with Federal Code 21 CFR Part 11.
We have a rich community of vetted industry experts with 15+ years of experience to whom we’d happily refer you.
We provide formatted templates for each section. All you need to do is enter in your information where appropriate. When you're done, you can download a fully formatted, professional-looking e-copy to submit to regulatory authorities.
Yes! Even if you already numbered all your tables, when you add in a new one, all the tables that come after it will be renumbered accordingly.
With our software, you only need to enter in key elements such as Indications of Use Statement once. The program will automatically enter into each appropriate section.
Well, without them, you are forced to make these types of changes manually. This can leave you vulnerable to errors and discrepancies which will lead to your submission being rejected.
We include the latest version of each FDA and MDR template. You no longer have to hunt them down and wonder if you found the right one.
Yes. You can assign seats to members of your team who will be submitting content for your application. You can also restrict what each team member has access to.
Our application builder integrates with Sharepoint, Dropbox, and Box. You can upload any document and insert it into the appropriate section of your application.
Yes! Every uploaded document is stored in a folder alongside your application. When your team sends an updated version, our system will make a note. This ensures you are always referencing the most up to date version.
We offer a free trial - click here to start your trial. If you would like to upgrade your plan to unlock all features, please contact us for pricing.
Our platform saves you over 40 hours of work, allows you to focus on more important tasks, produces an error-proof application, and helps manage your medical device throughout the entire lifecycle process.