CE marking harmonizes European technical legislation.
In order to obtain this marking, the manufacturer must draw up technical documentation that brings together the elements demonstrating that the product meets the safety and performance requirements demanded by European Regulation 2017/745 on medical devices (MDs).
The marketing of DM within the EU is subject to CE marking.
Pixacare Application is a solution capable of automating the classification of medical photographs by date and patient, and securing their storage. This solution was created to meet a real need among healthcare professionals who take medical photos, particularly from their personal smartphones.
This is complemented by the ability to document chronic or surgical wounds using a medical questionnaire. Photos, measurements and other clinical criteria relating to wounds are recorded in the patient file on the application. The data can be used to monitor the evolution of the wound.
Then, thanks to the remote monitoring and messaging functions, hospital practitioners can remotely monitor scarring in collaboration with community nurses.
As a result, Pixacare Application has been CE marked since December 28, 2022. More than just a formality, it's a genuine commitment to all our customers and users.
