Clinical Evaluation Plan and Report of a Radiological Imaging Software​​

Conducting a comprehensive literature review to substantiate clinical claims

Developing robust CEP and CER documentation aligned with EU MDR and MEDDEV 2.7/1 Rev. 4

Preparing a PMCF Plan tailored to the SaMD’s intended clinical use and risk profile

Collaborating closely with internal technical and clinical teams for accuracy and regulatory alignment

Accelerated documentation timelines through structured workflows and expert-driven processes

Enhanced audit readiness with clearly traceable, compliant regulatory documentation

Developed SaMD-specific CEP and CER integrating real-world evidence and software risk assessments

Ensured full alignment with EU MDR Annex XIV and MEDDEV 2.7/1 Rev. 4, demonstrating clinical benefit, performance, and intended purpose