In addition to being a prerequisite for many sources of public funding, qualifying my product as a medical device is structuring for my company. The claimed medical purpose is one of the most decisive elements. In particular, if my product creates new information likely to modify medical care, I check that it complies with the legal framework.

If my product is made up of several functionalities, I can choose to treat each functionality separately from a regulatory point of view. In this case, I answer the questions that follow for each functionality independently of the others.

Beware, regulations linked to health data and their processing are not considered through this question.

To help me see more clearly, I consult the G_NIUS Diagnosis: Is my solution a DM?