New Medical Device Usability Engineering Standard from MHLW

Usability engineering is now required when submitting applications to the Japanese authority.

IEC 62366-1, the international standard for usability engineering in medical device development, became a JIS standard in 2019 and was revised as JIS T62366-1:2022 in February 2022. The MHLW of Japan requires compliance with the revised JIS by March 31, 2024.

Emergo by UL provides support throughout the usability engineering process:

• Research – Research user needs to support design input.
• Analyze – Task analysis, know problem analysis and use-related risk analysis.
• Design – Develop designs that are intuitive, easy to use and that reduce the risk of use errors.
• Evaluate – Formative and summative evaluation support at each stage of product development.
• Training – We offer seminars and workshops upon request.

For any questions or requests regarding usability engineering, please contact us.