We are proud to hold the DIN EN ISO 13485 Certification, demonstrating our commitment to quality management systems in the design, production, and maintenance of medical devices. This internationally recognized standard ensures that we meet rigorous regulatory and customer requirements, allowing us to deliver products that meet the highest levels of safety and efficacy.
In addition to our DIN EN ISO 13485 certification, we comply with the regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), ensuring compliance with the latest European regulatory standards for in vitro diagnostic medical devices. This dual commitment highlights our dedication to maintaining the highest quality in every aspect of our operations, from design to post-market surveillance.
