The MDR has tightened the requirements for clinical data, particularly for class III devices, implantable medical devices and those whose conformity is based on equivalence data. If the available clinical data is insufficient, the medical device manufacturer must collect it through clinical investigations or PMCF measures. Planning, executing, and approving such studies can be time-consuming and require significant resources, but they also provide an opportunity to gather valuable clinical data and meet regulatory requirements efficiently.
We offer support in closing data gaps, developing effective market entry strategies, and successfully conducting feasibility analyses and study launches. Our customisable clinical data management and an efficiently designed process ensure reliable data collection that optimally supports your medical devices' smooth market entry. Our comprehensive clinical project management supports you in all phases of the clinical investigation – from the initial phase through the submission and execution of the study to the management and analysis of the data.
