Quality and Certificates
Our quality management system is certified to ISO 13485:2016, and our relevant product groups hold CE certification under the EU Medical Device Regulation (EU) 2017/745 (MDR).
Our certificates
ISO 13485:2016
Medical Devices Quality Management System
ISO 22716:2013
Cosmetics Good Manufacturing Practices (GMP)
CE – MDR (EU) 2017/745
CE certificate
Ethylene Oxide (EO)
Sterilization
Biocidal Product
Product documentation
Cosmetic Product
Product documentation
Quality and production together
- Medical Devices Quality Management System
- ISO 13485:2016
- Cosmetics Good Manufacturing Practices (GMP)
- ISO 22716:2013
- CE certification
- MDR (EU) 2017/745
- Sterilization
- Ethylene Oxide (EO)
- Indoor area
- 2,000 m²
- Cleanroom
- 400 m²
- Location
- Izmir Torbali Industrial Zone
25 of 43 products are sterile
Products supplied sterile are sterilized with the ethylene oxide (EO) method. Each product page lists the product's features, sizes and product codes.