Companies seeking to market a medical device in Europe need to create and maintain a Clinical Evaluation Report (CER).
The increase in responsibilities of the manufacturer as a result of recent changes to regulations has meant that, increasingly, manufacturers are asking us to work with them to create Clinical Evaluation Reports (often called Clinical Evaluation Reviews) for their products.
We work with clients to review clinical data that is relevant to the device and its intended use. We then evaluate the data to ascertain the safety and performance of the device. Finally, we utilise the available clinical data (including any clinical data that is needed to address otherwise outstanding issues) and establish conclusions relating to the performance and the safety of the medical device. All of this information is then compiled into the Clinical Evaluation Report.
Acorn Regulatory are acknowledged experts at CER creation and we have a long track record of working with companies from all over the world in assisting them to introduce their product into the European market.
If you would like to chat to us about Clinical Evaluation Reports and how we can help your company to maintain compliance or bring a new product to market in Europe, then get in touch today. Call us on 00353 52 61 76 706, email us: firstname.lastname@example.org or simply complete the details below and we will get back to you.