IRRAS Announces Notified Body Transition from GMED to DEKRA, a Global Leader in Inspection and Certifications
Stockholm, May 11, 2021 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the CE Mark certificates for its IRRAflow system and the company’s ISO13485:2016 certification have been transferred to a new notified body, DEKRA. After the successful completion of a recent audit by DEKRA, these CE Mark certificates for IRRAflow will remain valid until May 2024. “With DEKRA, we are building a relationship with one of the largest, most respected notified bodies in the world,” said Will Martin,