How Freyr Helped a US-based SaMD Company in maintaining EU MDR compliance with CER Medical Writing support

A US-based SaMD company specializing in radiation oncology software was struggling to address notified body non-conformities for its CE-marked product under EU MDR 2017/745. The client lacked the internal bandwidth to conduct an in-depth review of its Clinical Evaluation Report (CER) and needed support in identifying and bridging technical gaps. Ensuring compliance with evolving Regulatory expectations required a structured approach and expertise in literature review and clinical evidence correlation.

Explore the case study to learn how Freyr’s tailored CER medical writing services enabled the client to restructure its CER, address evidence gaps, and meet EU MDR submission requirements.