We have successfully obtained the ISO 13485 certification, an internationally recognized quality management system standard for organizations operating in the field of medical devices and medical equipment.
Until now, we have operated in accordance with the ISO 9001 standard, which confirms a well-established quality management system. With ISO 13485, we are taking this commitment one step further.
ISO 13485 is specifically tailored to the requirements of the medical industry, where safety, traceability, process control, and consistent compliance with regulatory requirements are of key importance. Simply put: ISO 13485 is our commitment to making no compromises when it comes to the quality and safety of medical devices.
For end users, this means more than formal compliance. It provides additional assurance that our design, production, control, and documentation processes meet the high requirements that apply to the medical equipment sector. The certification confirms that we systematically manage risks, ensure the traceability of materials and processes, and continuously work on improvements.
Our products are also compliant with the European Medical Device Regulation (MDR). Combined with ISO 13485, this means that we do not only follow good practices, but also meet the latest legal requirements of the European market. For users, this provides additional assurance that they are using high-quality and reliable equipment.
We are proud that by obtaining the ISO 13485 standard, we have confirmed our commitment to quality, safety, and reliability. Our goal remains the same: to provide users — medical staff and patients — with products and solutions they can trust.
