Completing additional Device Questionnaire
If you have selected Europe as one of the regulatory geographies, you will be presented with an additional device questionnaire. Answering the additional device questionnaire helps Essenvia recommend the device classification and rule as well as possible conformity assessment procedures.
The questions in the additional Device Questionnaire are dependent on the responses provided in the previous section of the Master Information for Device Questionnaire.
Completing Device Questionnaire
Device Characteristics is the second sub-category within Device information. The response to device characteristics is used to determine the kinds of specific information regulatory authorities will be requesting in regards to your device at the time ...
October 6, 2021: Duplicate Projects, Master Information Completion Percentage and bug fixes.
Duplicating Projects: We are adding new functionality to duplicate projects. Duplicating projects are useful in multiple scenarios including when you get an Additional Information (AI) request for which you only need to make changes to specific ...
Understanding Master Information
What is Master Information (MSI)? Master information (MSI) is a collection of the most common "mandatory attributes" used in regulatory documentation across the medical device lifecycle. MSI was carefully designed to combine fields across three ...
Preview and Publish
Overview Essenvia allows users to preview and publish a section or the entire project on-demand. Users can set account-wide publishing preferences that apply to any project created or override preferences for individual projects by setting project ...
Understanding Sections All Projects in Essenvia are a collection of sections (documents) created from templates. A template used for a Project becomes a section and can then be updated as per the specific regulatory requirements based on the type of ...