Spaces

Spaces

What are '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 solve 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, and it will be automatically cascaded into all projects related to the device. This removes the need to re-enter the exact details over and over again for each submission.

Spaces is shorthand for Device Workspace to help medical device companies manage all regulatory requirements for a single device.

If you are an account admin or space owner, we’ve explained features and workflows that will help you be most effective working within a space. By the end of this article you will be able to learn:
  • Benefits of a Space
  • How to create a Space
  • Space attributes:
    • Projects
    • Master information
    • Files (coming soon)
    • Team (coming soon)
    • Activity (coming soon)

Benefits of a Space 

  1. Sharing information seamlessly: Projects created in a space benefit from inheriting information from Master Information consistently. Files and documents created inside a space can be easily linked, embedded, or cross-referenced across the device lifecycle and across other projects within the space.
  2. Ensure team collaboration: The entire team added to a device space can be updated about the progress and goals. Artifacts can be created and shared easily across various team members.
  3. Consistent Master Information use: As more projects and documents are created in the space the team is aware of using the latest version of documents and information ensuring consistency and alignment at all times.
  4. Access rights and permissions: Managing permissions for team members and external collaborators is easy and can be managed by the space owners, therefore, taking the burden away from the account administrator.

How to create a Space? 

An account administrator or designated Space administrator can create a space using the following steps: 
  1. Click on the "New space" button to create a new space: 
     

 2. Name your space and select a theme to easily identify them


3. The spaces appear as cards as shown below:


Attributes of a Space

A space has the following core components that uniquely associate it with the device as shown below:
  1. Projects: Lists of all projects related to the device within the space. Learn more about projects here.
  2. Master information: Applicant, Device and Regulatory details associated with the device. Learn more about Master Information here

    • Related Articles

    • September 24, 2021: Introducing the New Project Manager and New Authoring Environment!

      Project Manager: We have redesigned Projects within the Spaces to make it easier to find all items related to your medical device. This update makes it even easier to manage your projects. You can read more about the changes including key changes and ...
    • Account Administrators (Admins)

      Who is an account administrator? The first registered user from a domain (for example acme.com) on Essenvia is automatically assigned as the administrator (admin) of the account. The user can delegate their administrator permissions to another user ...