Usability engineering according to IEC 62366-1

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

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.

Educational goals
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.

Recommended prior knowledge
The course is developed for participants who have a basic knowledge of medical device development and medical device legislation.

Course presentations
Course material will be in English, verbal presentation and discussions varies between Swedish and English, depending on the participants. The information can be found beside the course date.

Course leader
Cilla Lundevall, Principal Quality & Regulatory Consultant.