Quality Training

Application of Usability Engineering to Medical Device Software & IEC 62366


Use errors caused by inadequate Medical Device Usability have become an increasing cause for concern for Regulators, Medical Device Manufacturers and Healthcare providers alike. Many of the Medical Devices developed without applying a Usability (Human Factors) Engineering process are non-intuitive, difficult to learn and difficult to use. It is the responsibility of the Medical Device manufacturer to reduce all risk as far as possible including usability related risks. A functioning Usability Engineering process is essential for the Medical Manufacturer in attempting to minimise risk associated with the usability of their devices. This course outlines the requirements for a Usability Process as defined by EN IEC 62366 and the guidance available from the EU MDR, US FDA and MHRA. The course guides attendees thought the establishment of a Usability Process, how to achieve compliance with EN IEC 62366 and how to use the standard to minimise usability related risks.

Content includes

This interactive 1 day programme will include the contents of EN IEC 62366 and will examine in detail the requirements for establishment and maintenance of operation of a Usability Engineering Process in accordance with EN IEC 62304.

The requirements of EN IEC 62366 will be covered in detail including activities such as;
  • Preparation of a Use Specification
  • Identification of the User Interface characteristics related to safety
  • Identification of potential Use Errors
  • Identification of known or foreseeable Hazards and Hazardous Situations
  • Identification of hazard-related use scenarios
  • Selection of hazard-related use scenarios for Summative Evaluation
  • Performance of User Interface design and implementation
  • Performance of Formative Evaluation and preparation of a Formative Report
  • Performance of Summative Evaluation and preparation of a Summative

Risk Assessment
  • The relationship between EN IEC 62366 and the Medical Device Risk Management Standard EN ISO 14971.
  • The implementation of risk assessment to ensure critical use-related risks are identified and reduced as far as possible.

Usability Guidance
  • The guidance and approach contained in the guidance documents from EU MDR, US FDA and MHRA will be discussed and the relationship between these documents and EN IEC 62366 will be explored.

Who should attend

Personnel who need to gain a solid foundation in the principles and practices of Usability and Human Factors Engineering for
  • Medical Device Software,
  • Medical Device Hardware and
  • Disposable Medical Devices

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    Application of Usability Engineering to Medical Device Software & IEC 62366

    Training Days

    1 day

    Training Locations


    Course Cost

    Member: €390
    Non-member: €600
    *Membership is FREE for private sector companies in ROI
    * Cost quoted per person

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