Contents of Clinical Evaluation Report

The CER should contain all the documents required to prove the safety and performance of the device being evaluated. The three main sections are: 1. Scope of clinical evaluation : This section should include details of the device under evaluation, the technology used, directions for use, precautions etc. 2. Clinical background, current technology and state…

What is Medical Device Clinical Evaluation

What is Medical Device Clinical Evaluation Medical Device Clinical Evaluation : CE is a methodologically sound ongoing procedure to collect, appraise and analyze the clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device…