Evaluation of medical AI products

Target group

  • Start-ups
  • Medical software and DIGA developers

Your requirements

You want to launch an AI application on the market which is a software medical device. It has already been clarified to which medical device class the software belongs.

Our offer

Medical AI products usually have to demonstrate their benefit through proof of efficacy within the framework of studies. Based on the product information, methodological advice is provided on the creation of (supply) research concepts for your AI product.

The consulting may include:

  • the search for meaningful study designs that meet existing regulatory requirements,
  • the elaboration of possible outcomes and application options with third-party funding bodies.
  • Depending on the scope of the consultation, this may also include the preparation of a case number calculation so that the necessary size of a study population can be estimated.



Success stories

We provide advice on identifying appropriate study designs that meet the existing regulatory requirements for demonstrating the efficacy of the medical AI product.

Service type


Contact person

Bart de Noord

Planned start date

from now on