top of page

  • Discovering user needs to create the right product features for the right persona

  • Early on and iterative prototyping and testing to gather feedback

  • Incorporating user interface requirements and validating with actual users

  • Addressing stakeholder requirements and focusing on user needs

  • Establishing a corporate design and look and feel based on distinct form features

  • Close collaboration with subject matter experts from prototyping to manufacturing

  • Development of medical devices for home use, improving patient's independency

  • Assessment of use-related risk and usability problems

  • Design control documentation for submission to authorities in the U.S. and Europe (FDA, MDR-readiness)

  • Compliance to the FDA guidance Applying Human Factors and Usability Engineering to Medical Devices and the IEC 62366-1:2015+AMD1:2020 Application of usability engineering to medical devices

bottom of page