Clinical Evaluation

Essential to meet Medical Device Regulation (EU) 2017/745 & 746 requirements is the provision of current Clinical Data that supports the performance and safety claims made by the Manufacturer. GPB can assist with the review of pre-clinical and/or bench studies, Clinical Application and Clinical Evaluation.

Doctors performing surgery

GPB provide valuable expertise in assisting each client develop, implement and complete:

  • Test Protocols

  • Preparing & submitting investigation applications

  • Clinical Protocol(s) and Clinical Investigation Plans

  • Clinical Investigation Report(s)

  • Clinical Evaluation Report(s)

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

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