Category: product-updates

Being in charge of a regulatory submission for a medical device means managing a complex project with various moving parts and several contributors. If mismanaged, not only does the project face delays but your regulatory submission could get rejected. This will undoubtedly cost your company both time and money.

Essenvia is committed to ensuring this does not happen to your medical device. We provide a tool aimed at supporting your medical device throughout its entire regulatory lifecycle.

However, that support includes more than providing up-to-date templates and features that help compile an error-proof regulatory submission. We also keep the cross-functional teams in mind when making updates to our regulatory submission builder product. Our latest update focuses on providing a faster, cleaner, more user-friendly experience for anyone using Essenvia for their regulatory submissions.

Authoring Sections within Regulatory Submission

We worked with regulatory specialists to understand what improvements would optimize their overall workflow. Therefore, one of the pillars of our latest product update is the authoring environment for sections in the project. We have revamped the way you access the authoring environment as well as what is displayed in the authoring environment to give it a huge performance boost. The new “Project Section” screen from where you access the authoring environment will also list key information such as the status of the section, percentage completion, and who on the team has access to it.

The user experience enhancement to the authoring environment allows the user to focus strictly on the section at hand, while only the sub-sections for that particular section are viewable in the left-hand navigation menu.

Quickly Locate Key Project Management Information

As a project owner or manager, you have a lot of data and information to manage and report on. Therefore, we have completely overhauled project management within Essenvia to organize key data better. This includes providing a new status overview dashboard that provides real-time updates that can be shared with team members and key stakeholders.

With our new project overview screen, you now have key information at your fingertips, such as:

Project Status

• Days until due

• Percentage completion

• Draft or Published

• List of user activity

Section Status

• Number of sections in the draft state

• Number of sections currently under review

Making Cross-Functional Team Collaboration Easier Than Ever

We’ve made inviting a team member to collaborate on the project easier as well. You can share project access with a co-worker by inviting a team member directly from the “Team” screen within the project. You no longer need to add the team member at the account level before adding them to the project. This change will significantly reduce the number of steps and the amount of time it takes to provide project access to a team member.

Of course, you can still limit their access to what sections they can see and what types of permissions they have with your content. We’ve also made sure that account admins are notified any time a new member is added to the project.

As we mentioned earlier, part of the challenge of managing a regulatory submission is overseeing the contributions made by your cross-functional teams. These cross-functional department members consistently share documents, reports, images, and tables to upload into your submission. Our latest product update streamlines and simplifies the entire file management process.

Now, files can be found on their own screen within the project management dashboard. Within that screen, you can view every file that has been uploaded including document type and upload date. It also shows if a newer version has replaced a previously uploaded file. We’ve also added new filters for users to find the desired file much quicker.

Let’s Review

This product update is the latest in our unwavering commitment to helping regulatory specialists create an error-free regulatory submission in less time and with fewer headaches. We have revamped the user interface that makes authoring sections easier and more efficient. We also transformed our project management dashboard to include multiple tabs that make finding key information easier. Lastly, this update makes it easier to track file uploads, invite new team members, and respond to Additional Information requests from regulatory authorities by duplicating a project.

About Essenvia

Essenvia is a regulatory lifecycle management tool designed to help you optimize the entire regulatory operations process. Our solutions include an innovative approach to building your pre-market submissions like 510(k) and MDR as well as post-market submissions like Regulatory Change Assessment and Post Market Surveillance. Essenvia is designed to reduce errors, streamline processes, and guarantee faster regulatory clearance for your medical device.

Click here to try out Essenvia for free – no credit card required.

Click here to schedule a free demo.

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.