Usability engineering according to IEC 62366-1

Half day course

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.


  • 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.

Educational goals
After the course, participants will know what is required, from a regulatory perspective, to ensure good usability 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. The information can be found beside the course date.

Course leader
Cilla Lundevall, Senior Quality and Regulatory Consultant.

Dates and location



Online course
January, 18 2022 (English)

08.30 – 12.30


Onsite:  5 900, SEK

Online: 5 400, SEK


All prices excl. local VAT.

Group registration*

All prices excl. local VAT.

*For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.

Customized training courses and seminars

We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.

Send your request here

0 + 8 = ?