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.

Applying MEDDEV 2.7/1 revision 4 as a base we provide the necessary expertise to address the requirements of the MDR  / IVDR to develop, implement and complete:

  • Test Protocols to establish GSPR

  • Clinical Investigation Protocol(s) & Plans

  • Clinical investigation  / IDE applications

  • Clinical Investigation Report(s)

  • Clinical Evaluation Plan(s) & Report(s)

  • Post Market Clinical Follow Up (PMCF) and Trend Reports

We provide training in Clinical Evaluation (See Training) and the necessary support thereafter.

C L i C for Support