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.
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
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.