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