Prometheus DeltaTech now offers a Clinical Evaluation Report writing service. If a company plans to sell medical devices in Europe, it must produce and maintain a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the Medical Device Directive (MDD) or Medical Device Regulation (MDR) 2017/745. Such a CER is compiled by assessing and analysing clinical data regarding a medical device to verify the clinical safety and efficacy of the device.
Prometheus DeltaTech has a team of expert regulatory professionals together with an extremely large network of clinical experts, through our parent company’s clinical training faculty. Please follow the Device Services tab for more information.