Njord announce that it fulfils the requirements of the Regulation (EU) 2017/745 (MDR) and associated CE marking. Additionally, CB-certificate demonstrating conformity with 60601-1 Medical Electric Equipment has been issued by Intertek.
With the CE mark in place, Atle® 180 is now ready to be used clinically by healthcare professionals in the European market.
At Radiology departments there can be above 150,000 patient transfers done on a yearly basis. The transfers are conducted by up to five healthcare professionals, patients experience it as unpleasant, healthcare professionals derive stress and work-related injuries, and hospitals suffer from unbalanced throughput from the X-ray machines. Problems targeted by the novel patient transfer device Atle® 180.
Accelerated marketing and commercialisation across the first prioritised markets to follow.
“The CE mark for Atle and the related extensive testing done at Intertek to achieve external certification is an important milestone to lay the foundation for commercial acceleration in the European market with continued customer involvement and development. Grateful to work with our strong team members at Njord and partners making this happen," commented CEO Jacob Ahrnstein.