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 Clinical Evaluation Reports

Completing a Clinical Evaluation Report (CER) is like learning a new skill. At first, it can seem daunting and difficult, but once you learn a sensible way to execute it, it becomes much easier. Fang Consulting is here to assist your company on their path to producing a CER. Contact us with your questions regarding your CER needs.

  • A CER is an assessment of the data gathered, either through a literary analysis or through clinical trials, pertaining to the safety of your device in its intended use.
  • Stages of a CER are as follows:
    • Determine the scope of work
    • Find clinical data using:
      • Literary analysis
      • Clinical experience
      • Clinical investigation
    • Evaluate data to determine its relevancy, quality, and significance
    • Analyze the data to find its strengths and conclusions
    • Determine if findings are significant and sufficient
    • Produce the CER
  • A CER is required when seeking to market devices all over the world (even Class I devices)
  • Options for preparing a CER (according to MEDDEV 2.7.1 Rev. 4)
    • Perform a clinical study and summarize the results
    • Perform a literary study of relevant clinical literature
    • A combination of both

We help you review the data that is relevant to your device. We work the data gathered from clinical trials or through a literature review to evaluate the safety of your device in its intended use. Fang works with your company to create a CER, aiming to help make the path to completion an easier one.
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