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 of pertinent 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 app...