A clinical evaluation plan is a strategic plan that defines the clinical evaluation process required by MEDDEV 2.7/1 rev 4 and EU MDRRead More
Literature Search is a key part of clinical evaluation and an alternative pathway to clinical trials in order to prove the clinical safety and performance of your deviceRead More
CER documents the clinical evidence that proves the safety and performance of the medical device clinically, biologically and technically.Read More
The demonstration of equivalence allows the manufacturer to use clinical data from an equivalent device in the clinical evaluation to comply with the general safety and performance requirements of the MDR.Read More
Our CER writers are involved in a comprehensive review of clinical data derived from clinical settings, literature, state of art for assessing appropriate device safety and performance data. The CERs shall demonstrate conformity to GSPR, Benefit-Risk profile, and PMS activities.