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    Regulatory Essentials

    Regulatory Essentials in Health Tech: Usability and Labelling

    This on-demand session introduces the essentials for usability and labelling. Usability standard IEC 62366, user interface and human factors are explained. The session includes also a compact briefing of essential labelling, such as instructions for use, use of symbols and marketing claims.

    The Regulatory Essentials in Health Tech training series consists of 14 1,5-2 hour on-demand webinar sessions. Read more on the complete course page here >>

    Topics

    • Usability
      • What are usability, UX and human factors?
      • Why is usability important for medical devices?
      • The IEC 62366 standard on usability
      • User interface design principles
      • Usability engineering process for medical devices
    • Labelling
      • Instructions for Use and other labelling
      • Use of symbols
      • Unique Device Identifier (UDI)
      • Marketing claims

    Target group

    All health tech developers and stakeholders interested in gaining specific knowledge on how to apply the Usability and Labelling requirements on medical devices. Particular focus on start-up founders and staff, university innovator teams, young health tech professionals and new employees.

    Objectives

    • Understand the requirements and value of Usability Engineering as an essential part of medical device development.
    • Understand the principles of user interface design.
    • Are aware of the labeling requirements applicable to all medical devices by various regulations.

    Additional information

    It is recommended to follow the Regulatory Essentials sessions 1-4 before this on-demand session.