Regulatory Clinical Evaluation
Regulatory clinical evaluation for medical devices, made clear
Regulatory Clinical Evaluation
Regulatory clinical evaluation for medical devices, made clear
About RefineRCE
RCE stands for Regulatory Clinical Evaluation. At RefineRCE, we work to bring clarity, structure, and efficiency to the clinical evaluation process, enabling MedTech teams to deepen their understanding and make evidence-based decisions that pave the way toward MDR certification.
Our focus areas include:
- Clinical Evaluation Plans & Reports (CEP & CER)
- Investigator’s Brochures (IB)
- State-of-the-Art (SOTA) Literature Reviews
- Post-Market Clinical Follow-up (PMCF) Plans & Reports
- Scientific Writing & Data Interpretation