#Japan #Shibuya #Uism #PNUYH #Usability

Uism Partners with PNUYH

Introduction to the Partnership
Uism Corporation, headquartered in Shibuya, Tokyo and represented by CEO Yuki Asakawa, has established a strategic partnership with the usability center of Pusan National University Yangsan Hospital (PNUYH). This collaboration focuses on the evaluation of medical devices, reinforcing Uism’s capabilities to assist clients in their global expansion while streamlining the usability evaluation process in both Japan and South Korea.

Background of the Partnership

In recent years, there has been a rising demand for usability evaluations based on Human Factors Engineering (HFE) in the international medical device market due to regulatory requirements in various countries. While Uism has previously supported HFE evaluations domestically and in European and American markets, this partnership with PNUYH will allow for broader international support that includes the South Korean market, creating a more extensive global network for usability assessments.


The signing ceremony of the partnership: Yuki Asakawa (left) and Seokmin Yoon (right)

About the PNUYH Usability Center

The PNUYH usability center is recognized as a leading institution in South Korea for conducting usability assessments of medical devices. Notably, it was the first medical facility outside of the capital region to receive accreditation from the Korea Laboratory Accreditation Scheme (KOLAS) as a testing organization based on IEC 62366-1:2015 + AMD 1:2020.

Key Highlights of PNUYH Usability Center

• - Substantial Track Record: Since 2022, the number of evaluations has surged, achieving over 100 evaluations by the end of 2024, performing 30 to 50 evaluations annually as the only medical institution outside the capital region.
• - International Reliability: The KOLAS accreditation ensures that test results are mutually recognized in key regions including the Americas, Europe, and Asia.
• - Advanced Facilities: The center is equipped with four evaluation labs and two observation rooms that simulate actual environments such as hospital rooms, consultation rooms, operating rooms, and home settings, allowing for testing close to actual usage conditions.

Various labs simulate different medical environments

Implications of the Partnership

Uism is part of ReSight Global, a UX research group with bases in seven countries around the globe. This partnership aims to leverage this global network to create a system where Uism and PNUYH can synergistically support each other’s strengths.

Support for South Korean Companies Entering Global Markets

PNUYH will manage evaluations within South Korea, while Uism will provide support through ReSight Global’s network for compliance with HFE evaluations required in markets such as the US (FDA compliance), Japan, and Europe. This arrangement will offer a comprehensive support system for South Korean companies seeking international certification.

Assistance for Japanese Companies Entering the South Korean Market

For Uism clients, including Japanese companies requiring evaluation for the South Korean market or testing involving local medical practitioners and patients, Uism will facilitate the usability testing process utilizing PNUYH’s KOLAS-accredited facility.

Looking Ahead

Through this partnership, Uism aims to strengthen its role as a bridge connecting the medical device evaluation systems of Japan and South Korea. Moving forward, Uism will continue to utilize the international network of ReSight Global to ensure safe and effective medical devices reach patients worldwide.

For inquiries about this partnership, please contact:
Uism Corporation
Email: [email protected]
Company Info: Uism Website