RotoBed, MDR compliance and ISO 13485 certification
Read what CEO Martin Holm is saying
We have worked continuously with Blue Nordics since 2018, when we successfully launched our new RotoBed® products. In our collaboration, Blue Nordics has professionally handled the CE marking of the RotoBed® products. This has included, among other things, the preparation of our MDR documentation, including risk analysis, declaration of conformity, clinical evaluation report, and quality manual.
When we were visited by the Danish Medicines Agency in the summer of 2022 to review our documentation, Blue Nordics was also by our side. Everything went completely smoothly and according to regulations, and our CE marking as well as documentation for compliance with MDR were approved.
In connection with export markets that require documentation other than that required under MDR, Blue Nordics also assists us with this work.
During 2025 Blue Nordics has helped us to obtain ISO 13485 certification (Medical Quality Management).
The collaboration with Blue Nordics is always pleasant, constructive, and carried out punctually. Our highest recommendation!
