ISO 13485:2016

ISO 13485 is the medical industry's optimal medical device standard, which ensures that all
medical devices meet the proper regulatory compliance laws and customer needs.
ISO 13485 certification is a valuable credential put in place to keep professionals and customers
safe in clinics, hospitals and other medical settings.

View ISO 13485:2016

Certification of GMP

GMP (Good Manufacturing Practice) is the system accredited by the Ministry of Food and Drug
Safety for consumer safety. It is a quality control standard that ensures the manufacture and
supply of high-quality medical products, and it is applied to the entire process of the manufacture,
from raw material purchase, manufacture, packaging, storage and shipment, as well as the
structure of the facility

View certification of GMP

MFDS Market Approval

As a core regulatory framework in Korea, MFDS market approval validates the clinical efficacy
and structural integrity of advanced diagnostic technologies. For 'Newly Developed
Medical Devices', the MFDS conducts an intensive verification of the innovative mechanism
and long-term prognostic value, ensuring that only technologies with proven clinical
superiority are introduced to the medical community.

CE-IVDD

CE marking indicates that an IVD(In-Vitro Diagnostic) device complies with the European In-Vitro
Diagnostic Devices Directive (IVDD 98/79/EC) and that the device may be legally commercialized
in the EU.

View CE-IVDD

CAP Accreditation

CAP accreditation is an international clinical laboratory certification program administered
by the College of American Pathologists. It ensures the highest standards of quality management,
accuracy, and reliability in laboratory operations, including genomic analysis.
Achieving CAP accreditation demonstrates that a laboratory has established a world-class quality
management system and can provide patients with safe and trustworthy test results.

View CAP Accreditation

KIGTE Proficiency Testing

The proficiency testing from the Korea Institute of Genetic Testing Evaluation (KIGTE) is
an external program to check the accuracy of genetic tests. This annual test looks at the
whole process including DNA extraction and data analysis to make sure a laboratory keeps
the best quality and performance.

View KIGTE Proficiency Testing