Usability is an integral part of medical device development. Thus, it is important to understand how users may interact with a device, in order to ensure proper function and avoid safety issues.

To reduce the risk of use errors, the Medical Device Regulation (MDR) requires that medical devices be designed with specific focus on the characteristics of the intended users. The IEC 62366-1 standard describes the various activities that should be implemented in a usability engineering process to fulfill the requirements of the MDR.

Topics

• IEC 62366-1:2015 – History and regulatory context
• 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 quality and regulatory professionals.