Qualitative clinical evaluation (qCE)
The MDR has significantly raised the bar for clinical evaluations, adding layers of complexity to the process. This is particularly challenging for legacy devices with long market histories and Class III devices requiring frequent evaluation updates, where documentation continues to expand with each cycle.
Our solution is the quantitative clinical evaluation (qCE) methodology. This approach allows for statistically summarizing and graphically presenting the relevant safety and performance parameters, provided the data structure of published studies permits this (e.g., comparable endpoints, comparable study designs). Essentially functioning as a systematic review or meta-analysis, qCE strengthens the quality of your clinical evidence.
Beyond regulatory compliance, qCE is also excellently suited for scientific marketing. The graphical representation of the summarized data makes it possible to present the efficacy and safety of the medical device in an illustrative way and to convince potential customers or partners.
- Meta-analysis of available clinical data
- Clinical evaluation that's easy to update
- Evidence-based support for scientific marketing
