• Certification & Accreditation
Certification & Accreditation
Medical Device Manufacturing system
  • 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
IVD Certification

    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