Quality

We treat quality as a corporate culture, not a procedure.

All product development and manufacturing processes are carried out under the ISO 13485 quality management system. Our quality manual is accredited by KIWA.

ISO 13485

Standards Compliance

Our products comply with the latest versions of the following international standards:

  • EN 285
  • EN 865 / 866 / 867 / 868
  • ISO 13060
  • ISO 11138
  • ISO 11140
  • ISO 11607

These standards cover critical areas such as sterilization cycle verification, chemical and biological indicators, sterile barrier systems and packaging validation.

  • We are a GMDN-registered manufacturer.
  • We hold the Medical Device Manufacturer Certificate issued by the Republic of Türkiye.
  • We offer a CE-marked product portfolio.

Our quality processes are driven not only by regulation but by a commitment to lasting trust.

Documents & Certificates

ISO 13485

CE Certificate

Medical Device Manufacturer Certificate

GMDN Registration

KIWA Accreditation

93/42/EEC Compliance