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    Medical devices

    Usability engineering according to IEC 62366-1

    This one-day course, in cooperation with Intertek Academy, focuses on the usability engineering process, as described in the standard.
    Usability engineering is an integral part of medical device development. It is important to understand how users may interact with a device, to avoid safety issues and to ensure its proper functioning.

    To reduce the risk of use errors, both Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) require that devices are designed with respect to the intended use environment and the characteristics of the intended users. The IEC 62366-1:2015 + AMD1:2020 standard describes the various activities that should be implemented in a usability engineering process to fulfill the requirements of the MDR/IVDR.

    This course focuses on the usability engineering process, as described in the standard. The course contains both theoretical sessions and practical exercises.

    Topics

    • History and regulatory context of the standard
    • Usability – terminology and definitions
    • The usability engineering process – step by step
    • Formal usability validation
    • Legacy devices

    Trainers

    Cilla Lundevall Wiberg
    Cilla Lundevall Wiberg
    Principal Quality & Regulatory Consultant
    Cilla has 25+ years of experience from the Medical Device field, mainly from Quality assurance in product development of SaMD and large complex systems, but also from manufacturing processes. Cilla is an active expert in national and international standardization committees, experienced change leader and has supported many medical device manufacturers in their usability engineering work.

    Target group

    This course is intended for personnel involved in medical device development, including but not limited to, quality and regulatory professionals as well as user interface designers. The course is developed for participants who have a basic knowledge of medical device development and medical device legislation.

    Objectives

    After the course, participants will have a good understanding of what is required, from a regulatory perspective, to establish a usability engineering file for a medical device. After a successfully completed course, participants will receive a certificate.

    Additional information

    The course costs 8 100 SEK (excluding local VAT). The course material is in English, and the course will be held in English.

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