CERdev - MDR Clinical Evaluations

We specialize in developing the most critical part of the technical documentation – the Clinical Evaluation – in line with the latest regulatory requirements and the expectations of Notified Bodies under MDR 2017/745. What can we do for you? 1. Prepare a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) fully compliant with MDR 2. Update your existing documentation to meet MDR requirements 3. Create a well-structured literature search protocol and assess the resulting data 4. Conduct periodic reviews of your Clinical Evaluation 5. Deliver a Preclinical Report for your new medical device 6. Advise you on updating your technical documentation We draw on hands-on experience across a wide range of projects and medical device classes. We understand which aspects tend to raise questions from Notified Bodies – and we use that insight to build documentation that’s thorough, focused, and helps you avoid time-consuming revisions.