Completing 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 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. 

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