A Clinical Evaluation Report (CER) comprises of analyzed clinical data derived from a clinical investigation, or the collective results and literatures from other studies of equivalent medical devices. The report shall demonstrate results that the device has met the safety requirements and fulfill the intended use.
Content topics such as product materials and performance, clinical data from existing literature, clinical trial and studies. comparison between comparative device and exemption of clinical trial catalogue, analysis review of approved domestic medical device shall be taken into consideration while writing CER.
Requirements of CER tend to be more stringent, for instance in China as compared to CE, therefore OSMUNDA Group offers medical writing service to accommodate with your commercial and oversea expansion operation.