What are the 6 Essentials of a Clinical Evaluation Report (CER)?

 Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device.

6 Requirements of a Clinical Evaluation Report for Medical Device Manufacturers –

·         Scope and plan

·         Identification of pertinent data

·         Appraisal ofpertinent data

·         Analysis of the clinical data

·         Finalize the report

·         Physician Review & Approval

 

After data analysis, the evaluation report should summarize the data analysis. This report should provide strong clinical evidence for conformity assessment so the device can be approved for sale in European markets.

IZiel completes the Clinical Evaluation Report (CER) as per the following changes in revision Med-Dev Rev. 4 with focus on detailing and clarity on every step of the clinical evaluation process that has been conducted by the manufacturers and evaluators.