Essenvia Spaces: All Your Medical Device Data In One Place

Being in charge of a device’s regulatory information is complicated enough. Being tasked with managing this type of data for various devices can be overwhelming. Even if you are only working on one device, you deserve the ability to organize and manage files, processes, and projects related to regulatory submissions.

Essenvia was born out of a need to streamline the regulatory process throughout the entire lifecycle of a medical device. Spaces is the latest step in that journey.

What is ‘Spaces’?

Currently, on the Essenvia platform, every project created for a specific medical device operates in its own silo. In other words, if a piece of your device’s master information changes in one project, you must manually make this change in the other projects. Spaces solves this tedious and time-consuming issue.

‘Spaces’ is shorthand for ‘Device Workspace,’ and it’s our solution to help you manage all the regulatory submissions related to a particular medical device. As an account administrator or space owner, you can create a ‘Space’ for each device you are working on.

Then, you create all projects associated with the device in its own dedicated space. This way, you only need to fill in the Master Information once. Then, it will be automatically cascaded into all projects related to the device. This removes the need to re-enter the exact details repeatedly for each submission.

A Must Have For Managing Multiple Devices

Spaces are vital in efficiently managing multiple projects and documents for the same medical device. It is also the ideal solution for regulatory managers in charge of managing a portfolio of devices. Regulatory consultants who support multiple projects and clients simultaneously can take advantage of the advanced permissions features. It is now easier for consultants to manage permissions for their customer’s regulatory projects, files, and devices.

Spaces was designed to optimize how a device’s regulatory management as it moves from stage to stage. Our tool ensures crucial information, files, and data stay consistent. It also allows sharing and collaboration to be easily managed. This is a key component when creating an expedited and accurate regulatory submission.

Aligning On Your Device’s Key Information And Other Medical Device Data

A core function of the Essenvia platform is to capture your Master Information at the beginning. This includes all of your applicant, device, and regulatory details. Spaces ensures that the vital information you entered at the start is shared across all the projects (submissions) within the space. If that information suddenly changes, those changes are then automatically cascaded across all submissions.

Spaces ensure that the data we collect is shared with every member of your team. When everyone is working off the correct information, the likelihood of errors and delays drops significantly.

If a piece of your master information changes, your entire team must be notified. Otherwise, you have team members creating documents with outdated data. That type of mistake can force you to waste time fixing errors. Even worse, if it is not caught in time, it could cause your regulatory authority to reject your submission entirely.

Tracking Your Team’s Access and Permissions

Pushing a device through critical regulatory milestones requires plenty of help from your functional teams. Spaces are perfect for providing a central location to make their contributions. However, we are fully aware that some contributors require more access than others. Plus, your internal team members will likely need greater access than external vendors

Spaces allows you to keep complete control over who has access to your space and how much they can do and see. In addition, our varying permission levels will enable you to grant access based on need. For example, a design agency creating your images does not need the same level of access as a research specialist or project manager.

Track All Key Aspects Of Your Space and Medical Device Data

A medical device will encounter hundreds of changes throughout its regulatory lifecycle. This will include new submissions, key information updates, tables, reports, files, etc. Spaces allow you to track all the activity within the space so that you have an activity log that captures all the updates or changes as required by the regulatory authorities

How To Learn More About Spaces

Spaces was created to optimize the regulatory process across the entire lifecycle of your medical devices. Our latest feature is ready to help streamline managing different submissions for each device, reducing repetitive work and errors, and manage all aspects of your device’s regulatory life cycle.

Sign up for a free trial, CLICK HERE.

If you are interested in scheduling a demo session, CLICK HERE.

To learn more about Essenvia and the features we offer, CLICK HERE.

5 Reasons You Shouldn’t Submit Your 510(k) Submission Alone

First, you conceptualize your idea for a new medical device. Your team has determined what medical issue it is going to resolve and how it will be used. Then, you research the current state of the market to understand the level of need and how to best position it. Your cross-functional teams spend time designing your device and ensuring it is easy to use. Finally, you are ready build your 510(k) submission to submit your device for FDA clearance.

 Obtaining FDA clearance for your device involves submitting a 510(k) application. This application is normally over 1,100 pages and requires a plethora of information. The sheer size of this application will leave you open to all types of mistakes. Theses mistakes can lead to your application being rejected.

The FDA will provide general guidance regarding what needs to be included in a 510(k) application. However, they provide little else in terms of document organization or project management. This often leaves submitters alone with a checklist and blank Microsoft word document. Then forced to wrangle hundreds of pages of information such as packaging labels, clinical trial reports and more.

In this post, we cover the top 5 reasons why you should not go it alone when submitting your 510(k) application.

#1 – You Need To Have The Most Up To Date FDA Documents

Your 510(k) application, you will include several places that require FDA documents. The FDA will supply these documents as they are necessary for submitting a complete application. However, documents and forms such as your Cover Sheet, Indication of Use, and Declaration of Conformity to a Recognized standard change often. It can be difficult to know if you are using the most up-to-date version. The last thing you want is to learn you are not compliant by having your application rejected.

These types of requirements can lead to errors among those who are doing this on their own. However, using a 510(k) application builder tool like ours ensures you always have to right templates. We automatically populate your application with the most up-to-date FDA templates. All you need to do is fill in the necessary information.

For example, the FDA requires a specific form for your device’s Indication of Use statement. This document explains what you plan to use your device for after receiving clearance. This is also a document that the FDA tends to update regularly. As anyone who has used the FDA website will tell you, these documents are not easily accessible. Our 510(k) builder always provides the most up-to-date form and automatically inserts it into your application.

#2 – Discrepancies and Errors Will Lead To Rejection Of Your 510(k) Submission

A key reason automation has become so popular in today’s society is it cuts down on both time and errors. Brands no longer require their sales reps to manually type out their outreach emails because it is highly likely there will be a typo or incorrect statement. The pitfalls of manual data entry are just as evident when it comes to 510(k) applications.

The application will require you to repeat the same key information such as indications for us and device descriptions in several places. For example, your indication of use statement is a key point that the FDA will review. Even if you are clear on what that statement is, it’s possible it can be phrased in several different ways.

If the reviewer feels this statement is inconsistent, they will reject your application. In our application builder, we ensure this type of content is consistent throughout your entire application. All you need to do is type it once and our Changelock™ function ensures your information cascades to all relevant sections throughout your application.

#3 – You Have A Lot Of People You Need To Communicate With

As the saying goes: If you want something done right, do it yourself. Regardless if you agree, one undeniably true fact is that you cannot compile the data and information you need for a 510(k) by yourself. As the project lead, you are required to communicate with several people both inside and outside your organization. This requires countless emails, dropbox folders, JIRA tickets, and anything else that delivers the content you require.

Ongoing communication amongst this many parties is ripe for confusion and errors. This is due in large part to your teammates not being well versed in regulatory terminology. They are also not nearly as knowledgeable as you are about the various requirements set by the FDA. Therefore, it is your responsibility to translate their work into content that follows the proper terminology and requirements.

A system must be put in place on day one. A process that allows you to get a handle on the various documents that are floating in your direction. You will benefit greatly from a program that helps collect this information and store it in an organized manner. This will relieve your stress and allow you to confidently move forward knowing you have the most up-to-date and accurate versions of everything you need.

#4 – The Fear and Anxiousness Of Getting You 510(k) Submission Wrong

Gaining FDA approval is a daunting and pressure-packed task. This is the major hurdle stopping your device from hitting the market and turning a profit for your organization. Key stakeholders including executives, shareholders, investors, and team members are looking for you to deliver. Messing up could mean a loss in revenue, decreased profits, and possibly even losing key investments. That scenario is enough to paralyze anyone with fear and anxiety.

While you cannot minimize the importance of a 510(k) application or decrease its size, you can determine the best way to approach it. This includes setting up a process that safeguards against errors, discrepancies, and the use of outdated documents. When you leverage the power of our app builder, you no longer fear making a crucial mistake such as using the wrong template or forgetting to update a section of your application. Your anxiety will significantly lessen knowing you took the necessary steps to produce an error-free and rejection-proof application.

#5 – Your Time Is Better Spent On Other Sections Of Your 510(k) Submission

The truth of the matter is your time is precious and better served working on other things. While putting together this submission may be your top priority, that does mean you have time to waste hunting down the latest FDA documents and ensuring the information people are sending you is up to date. Furthermore, it should not be your responsibility to then take these thousands of pages and attempt to use Microsoft Word to comply with the FDA’s mandated e-copy format.

On the topic of time-consuming tasks, it is worth talking about the RTA checklist that is required at the end of each submission. This is a time-consuming document that appears after you just spent countless hours compiling and formatting your entire application. Our software will automatically tell you which parts of this checklist apply to your device. Then, it provides a convenient function that allows you to answer the questions as you complete the section instead of at the end of the process.

We can’t perform most of the leg work for you but we will make it easier to compile and organize what you do collect. We also make sure you are not wasting your time worrying whether or not what you are submitting will be rejected by the FDA. The time we save you can be better spent tending to your other tasks and responsibilities.

Conclusion

Submitting a 510(k) application is a complex process that requires the help of an experienced expert. The sheer size of this project leaves most people open to errors and mistakes that result in being rejected. Our program has identified these common areas of mistake and provides solutions to ensure that they do not happen to you. Together, we can submit a 510(k) application that you can feel confident will be approved by the FDA.

About Essenvia

Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.

Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510(k) submission.

510(k) submission

The Top 5 Reasons The FDA Rejects A 510(k) Submission

If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes. You spend hours and hours collecting data and documents from various departments. You then spend more time finding the right templates and trying to understand the FDA’s guidelines. Plus, you have to search for the most up-to-date templates to use. After all of this hard work, the last thing you want is to discover the FDA has rejected your application.

Unfortunately, this is what happens to over 64% of 510(k) applications submitted for FDA clearance. Over 30% of these applications are not even accepted for initial review. Having a worthy device and the content to back it up is not enough to achieve FDA clearance. In this post, we cover the 5 most common reasons a 510(k) gets flagged and to avoid it.

#1 – Using Incorrect Or Out of Date FDA Templates

There are several sections throughout your 510(k) submission that require you to use some type of FDA-issued form. These sections include your Medical Device User Fee Cover Sheet (From FDA 3601), CDRH Premarket Coversheet (Form 3514), Cover Letter, and Indications for Use (Form 3381). Each section requires you to use the latest FDA-approved template when submitting your application.

The FDA is regularly updating these templates which makes it increasingly difficult to keep yup. While using the wrong template may not result in an outright rejection, it does put your application at risk of leaving out key information. Essenvia’s 510k application builder will always supply you with the most up-to-date templates. This helps avoid wasting hours scouring the internet and hoping you found the right templates. Furthermore, you can submit your application in confidence and no longer worry about submitting an out-of-date template and missing key information.

#2 – Discrepancies In Information That Appears More Than Once

As we mentioned above, the quality of your device and the content you provide are only part of this complex process. The FDA is quite strict when it comes to consistency in the information you provide. For example, your Indication for Use Statement appears over 20 times in your application and the FDA requires it remains the same throughout. Even if the intent remains unchanged, your application will be flagged, paused, and possibly even rejected if the wording does not match up.

It may seem simple enough to pay extra special attention when repeating information throughout your application. However, what happens when something changes towards the end of your process? You are now forced to scan your entire document and manually make this change each time. With Essenvia, this tedious type of work is done for you. With our Changelock™ feature, once you make this change on one page, it cascades throughout your entire document. You no longer have to worry if you missed a section during your review.

#3 – Not Following The 510(k) Submission Refusal To Accept Checklist

As we mentioned earlier, over 30% of submissions are rejected before they are even reviewed by a real person. This is due to their failure to comply with the Refusal To Accept checklist. In simple terms, the RTA checklist is what the FDA uses to determine if your device meets the minimum threshold for review. This document proves that you are worthy of the FDA’s time and have a realistic shot of gaining clearance.

This checklist consists of 56 questions all about the content and information in each section of your application. If you want until the end to fill it out, you risk providing answers that are not consistent with what you provided earlier. It’s important to note that not every question applies to your device. Our application builder not only shows you which questions are applicable but allows you to answer them as you are putting your sections together.

#4 – Choosing The Incorrect Predicate Device For Your 510(k) Submission

As you may already be aware, the FDA requires all submissions to list a predicate device on their application. Essentially, it is your responsibility to select a device already on the market that is substantially equivalent to the device you are seeking approval for. This is one key way the FDA can determine if your device is safe and effective. You can review current devices and their information by searching the FDA’s medical device databases.

Your Indication of Use Statement must align with the predicate device you have chosen. Whatever you decide your device is going to do it must match up with what your predicate device already does. It is equally important that your device’s technological characteristics are similar to those of the predicate device you have chosen. To increase your chances of clearance, you can include a side-by-side comparison for the reviewer to examine.

#5 – Skipping Not Applicable Sections In Your 510(k) Submission

While a traditional 510(k) includes 20 sections, not every single one of them will apply to your device. This includes sections such as Class 3 Summary and Certification, Financial Certification or Disclosure Statement, Performance Testing (Bench and Clinical) Proposed Labeling, Biocompatibility, Sterilization, and Shelf Life, and Electromagnetic Compatibility and Electrical Safety. A common mistake made by first-time submitters is leaving these sections blank instead of using a standard not applicable statement.

Even if the section does not apply to you, you are still required to state that in writing. Our application builder software will auto-populate these sections with pre-approved statements. This allows you to move past these parts of the application and focus on those that are applicable and important.

Conclusion

As you can see, compiling the content and data is only half the battle. The FDA expects and requires you to follow various guidelines and procedures. These requirements are why investing in a support program like Essenvia will return a high ROI. Together, we can make sure you submit a rejection proof 510(k) application and that all of your hard work will be worth it.

About Essenvia

Essenvia is an online software to streamline pre and post-market workflow for medical device companies by streamlining plans or activities to market, improving cross-functional collaboration, and automating steps to manage initial and subsequent device modifications.

Our tool is designed to help drastically reduce submission errors, streamline data and information gathering, save time, and help you submit a close to rejection proof as possible 510k submission.