Usability engineering according to IEC 62366-1
This course focuses on the usability engineering process, as described in the standard. The course contains both theoretical sessions and practical exercises.
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.
Topics
- History and regulatory context of the standard
- Usability – terminology and definitions
- The usability engineering process – step by step
- Formal usability validation
- Legacy devices
Course leader: Cilla Lundevall, Senior Quality and Regulatory Consultant.
What is your area of expertise within the Medical Device industry?
“Software verification and validation is where I started off, so the software domain is close to my heart. But as my curiosity makes me want to learn “everything”, I have nowadays a rather broad experience within quality assurance of medical devices. My expertise is to see the full picture, to draw up strategies and plans. In my job, I enjoy assignments where I can help companies in breeding a pragmatic quality culture that includes all personnel – a sound basis for development and manufacturing of excellent products!”