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 of submission. Completing a set of simple Yes and No questions takes under a minute to complete and helps Essenvia complete up to 20% of your 510(k) or CE mark application by filtering out any non-relevant requirements and sections.
In the example here, for a device that does not contain software and the response is marked 'No':
Essenvia automatically completes the Software section based on the response in the Device Questionnaire:
A completed device questionnaire is required to fast-track your regulatory submissions by not only completing the sections but also identifying sections and requirements that are not applicable for your regulatory submission. This means you can focus on rallying your teams towards high-value activities and goals.
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 ...
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 ...
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 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 ...
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 ...