Njord Medtech today announced it has been awarded ISO 13485:2016 certification by RISE, demonstrating the company’s commitment to comply with the most rigorous global regulatory and quality standards.
ISO 13485 is an internationally recognized quality standard for quality management systems, created by the International Organization for Standardization to ensure the safety and effectiveness of medical devices. It builds on the ISO 9001 standard with additional regulatory requirements specific to medical devices. In 2024, the U.S. Food and Drug Administration issued the Quality Management System Regulation (QMSR) Final Rule, which harmonises U.S. requirements with global standards through the adoption of ISO 13485 standards for medical devices.
“We are proud of the robust systems our team has built, ensuring stringent control over development and manufacturing processes. This certification demonstrates our ongoing ability to meet exacting regulatory requirements as we continue to achieve commercial, clinical and developmental milestones with Atle® 180 and ongoing product development” said Jacob Ahrnstein, Chief Executive Officer of Njord Medtech.