Clinical Evaluation

Meeting Medical Device Regulation (EU) 2017/745 (MDR) & 746 (IVDR) and other national requirements, to provide Clinical Data that supports the medical device performance and safety claims.

Using our expertise we assist you review pre-clinical and/or bench studies, assess substantial equivalence, complete literature reviews, establish clinical protocols, clinical investigation / IDE applications, clinical investigations plans & reports in accordance with ISO 14155.

Evidencing medical device safety and clinical performance & completing Clinical Evaluation in compliance with EC, FDA and other national regulatory requirements.