DRGEM Advances Medical X-ray Safety with UL Solutions-Aligned Certification Infrastructure
DRGEM (CEO J. B. Park) has completed the construction of a certification infrastructure at its Gimcheon factory. This enables the independent execution of major safety tests under the witness of UL Solutions. This achievement marks a strategic turning point. As a result, the company has fully internalized international standard-based testing capabilities within the organization. By securing a system that enables integrated management of the entire process—from the initial product development stage to testing and verification—DRGEM has further strengthened its global quality response capabilities.
Understanding UL Solutions: The Standard for Global Quality
UL Solutions is a global leader in applied safety science, testing and evaluating products according to international standards for the safety and essential performance of medical electrical equipment, such as UL60601. In particular, meeting UL Solutions standards is a key requirement for entering the North American market. It also serves as a critical metric for gauging the quality competitiveness of global medical devices.
Realizing Optimal Infrastructure for Independent Verification Systems
The DRGEM Gimcheon factory has systematically established the environment necessary to perform ‘Safety Full Tests.’ The factory has completed the installation of single-phase and three-phase CVCF power facilities, constant temperature and humidity chambers, and precision temperature measurement systems. Furthermore, the introduction of dedicated testing equipment and jigs, along with the expansion of electrical infrastructure in shielded rooms, has been finalized. By establishing a test execution and data management system that meets the requirements of UL Solutions, DRGEM has significantly enhanced the reliability, traceability, and reproducibility of all test results.
Accelerating Global Market Supply and Securing Technical Trust
The registration as a UL Solutions Witness Test Lab is deeply significant in that DRGEM has evolved beyond simply meeting global quality standards through external agencies to establishing them as a core internal capability. Through the construction of this certification infrastructure, safety requirements can be verified immediately from the development stage, increasing design efficiency. As the overall schedule from the start of testing to the acquisition of certification is shortened, it has become possible to supply products to medical institutions worldwide more quickly and reliably. Building on this achievement, DRGEM plans to continue growing as a Global X-ray specialist company trusted by medical institutions around the world.
