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User Interface

To enable users to interact with the device effectively, organisations may develop some kind of user interface (UI) that facilitates tasks such as uploading images, viewing reports, and utilizing the device's features.

To help organisations in the process of developing a user interface, and to comply with Annex I, Article 17.1 of the MDR, this section outlines the key elements of the user interface, their purposes, and how they assist healthcare professionals (HCPs) in making informed decisions about patient care.

The user interface is divided into three main sections:

  • Instructions for capturing images.
  • Reports generated by the device.
  • Label for regulatory compliance.

Each section plays a crucial role in enhancing the user experience and should be designed for clarity, ease of use and regulatory compliance.