We are pleased to announce that Iskra ISD has officially obtained the ISO 13485 certification, a key international standard for quality management systems in the field of medical devices.
This achievement confirms our ability to meet strict regulatory and customer requirements for the development and production of medical components and assemblies. It also represents a significant step forward in expanding our competencies and partnerships in the medical sector.
The certification process was successfully completed thanks to the expertise and dedication of our teams. We especially acknowledge the contributions of Boštjan Gaser (Plastics), Lea Kasunić (Turning), and Aleš Slak (Services), as well as all colleagues who supported documentation and audit activities.
With ISO 13485 in place, Iskra ISD is now even better positioned to support customers in delivering safe, high-quality, and compliant medical products.
Also, check our Medical - Turned components leaflet.
