Quality & regulatory
Quality at every stage.
Certified in Europe and registered in markets from Brazil to Saudi Arabia.
Design, materials, production and documentation: every step that decides how an implant performs is in our own hands.
Quality at all levels
Engineeringdesigned in-house
Productionmachining to packaging in Ankara
Instrument setsown design and production
ISO 13485quality management system
EU MDRcertified device families
Certifications & registrations
Certified in Europe, registered worldwide
- EU MDRRegulation (EU) 2017/745Certified device families
- CECE markingConformity for the EU market
- ISO 13485Quality systemDesign and manufacture
- ANVISABrazilProduct registrations
- COFEPRISMexicoProduct registrations
- INVIMAColombiaProduct registrations
- SFDASaudi ArabiaProduct registrations
- MHRAUnited KingdomDevice registrations
Our other product families are CE-marked under the MDD during the MDR transition. Country registrations are held market by market with our local partners. Certificate copies are available to partners and tender teams on request.
In production
Quality you can trace
Quality policy
Our quality commitments
- We will keep improving our quality management system and maintain its effectiveness.
- We will build lasting relationships after sales and provide useful products and services.
- We aim for production of the highest quality at a reasonable cost, starting at the design stage.
- We will value the ideas of our customers and employees.
- We will create a workplace where our employees are happy and proud of the work they do.
- We undertake to observe the regulatory requirements that apply to each product family: Regulation (EU) 2017/745 (MDR) for the families named on our MDR certificates, and the transitional provisions for families CE-marked under the MDD.