Scientific analyses

When developing a product for the regulated healthcare market, data is often either already generated within the company or data is already available from the best available external evidence. From this, a product can often already be positioned very precisely in the market or its safety and efficacy can be proven. In addition, the analysis of existing results from daily practice can lead to considerable knowledge gain and it can be derived from this whether a clinical study / clinical trial is necessary or which case numbers should be estimated for a meaningful study, which indication or which patients should be selected.

In the case of medical devices, the new EU Medical Devices Regulation (EU MDR 2017/745) requires this of manufacturers for medical devices of all risk classes. This is called clinical evaluation in that case (see below for more) and applies both before and after a medical device is placed on the market.

Our experience with scientific analysis extends to:

• Analysis of real data sets
• Retrospective analyses
• Literature research
• Generate state of science
• Clinical evaluation according to MDR
• Define open medical needs
• Impact evaluation / evidence of effectiveness