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.
WHAT IS A CER?
- 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
HOW FANG CONSULTING CAN HELP
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.