IEC 62366 - Medical Device Usability

It is important to consider usability during the development of medical devices. Knowing how users handle the device is essential to avoid usability-related safety issues and ensure proper functioning.

The European Medical Device Regulations, MDR and IVDR, require that products are designed taking into account both the intended user and the intended environment of use, to reduce risks related to usability. The international standard IEC 62366-1:2015 and AMD1:2020 describes the activities that should be implemented in a process to meet the requirements of MDR/IVDR.

This one-day course focuses on the process described in the usability standard. The course includes both theoretical sessions and practical exercises in activities included in the standard.

From the program

• History and regulatory context
• Review of the main definitions of the standard
• The process - step by step
• In-depth look at summative evaluation
• How do we meet the standard for legacy products?

Target group

The course is primarily intended for those who work with the development of medical devices, e.g. product owners, product developers, UX designers, testers, risk managers, QA/RA, but is also aimed at product development managers, marketing staff and users.

Learning objectives

After the course, you will have a good understanding of what is required from a regulatory perspective, to establish a “Usability Engineering File” for a medical device. After completing the course, a course certificate is issued to successful participants.

Prior knowledge

The course is adapted for participants who have basic knowledge of medical device development and medical device legislation.

Course leaders

The training is conducted in collaboration with QAdvis.

Upcoming classes

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