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.

Schedule a demo now to find out how Essenvia can help you with your regulatory submissions.