MDR & IVDR Compliance Service for Medical Devices / QMS Outsourcing

Out-sourcing Quality Management

Today organizations have to decide to either cut down portfolio or triple their QA/RA team. At Orange-Moon we understand that this is a painful process if you are on your own.

In this situation “Quality Management as a Service” is an efficient choice. Talk to us to explore other options turning the sensed threat of MDR/IVDR transition into advantage.

Automation in audits? Yes we can!

Orange-Moon is the only company that is providing semi-automated audits and assessments. These services are running in the background of our system. The result: highly efficient certification processes under MDR / IVDR (EU 745/17 EU 746/17).