Samsung Seoul Hospital Selected as Implementing Agency for 'Medical Device Usability Infrastructure Establishment Project'

Samsung Seoul Hospital.

[Asia Economy Reporter Lee Gwan-joo] Samsung Medical Center announced on the 16th that its in-hospital Medical Device Usability Testing Center has been selected as an executing institution for the "Medical Device Usability Infrastructure Establishment Project" by the Korea Health Industry Development Institute (KHIDI) under the Ministry of Health and Welfare.

Usability testing aims to identify and minimize potential user errors that may occur during product use at the medical device development stage, thereby enhancing the safety related to the device's usability. Starting from July, all domestic medical devices of all classes will be required to undergo mandatory testing at the time of product approval.

Since 2017, Samsung Medical Center's Medical Device Testing Center has established dedicated spaces and facilities to conduct usability testing and has been providing related services. Last month, it also obtained certification as an international medical device quality management system implementing organization (ISO 13485:2016 & EN ISO 13485:2016) from the British Standards Institution (BSI). ISO 13485 is an international standard established by the International Organization for Standardization (ISO), proving that the services provided by the center comply with international standards.

A representative from Samsung Medical Center stated, “Based on the accumulated experience and capabilities in conducting tests, we plan to support global-level medical device usability evaluation services for domestic medical device companies,” adding, “We also plan to offer educational services along with accurate technical information provision.”

This content was produced with the assistance of AI translation services.