banner image showing an article in the medical devices / AI space.medical device manufactorer developing an ML/AI-based SaMD

Products & Services

Thumbnail of webinar "AI for medical Imaging - Development and documentation according to MDR and FDA".


Our workshop "AI for medical imaging - Development and documentation according to MDR and FDA" is the perfect sweep. It covers technical and regulatory topics from the birds-eye perspective and then dives into a concrete example of an AI-based medical device that the attendees will audit during the workshop.

Find out more about this workshop on the page of the upcoming open-format date. Upon request, the workshop is also available in an in-house format in both English and German.

Image of deep learning frameworks "TensorFlow", "PyTorch", and "Keras". These libraries must be validated as SOUP and/or tool according to the MDR if used in a AI medical device.

Tool & SOUP Validation

You most likely don't develop deep learning models from scratch but use libraries such as TensorFlow and PyTorch.
According to the medical devices regulation (MDR), these libraries have to be validated for use in a medical device. If they are used only during the training of the model, they are software tools according to the MDR. If they are used during inference, they are called SOUP (software of unknown provenance).

Usually, they are used during both of these activities. We have developed a light-weight solution that achieves regulatory compliance with minimal effort.

Image of a magnifying glass "explaining" a deep neural network.

Explainable AI Toolkit

AI explainability has become the center of much attention around fairness, ethics, safety, and effectiveness. We've observed auditors pay increased attention to explainability as well.

We've developed a lightweight solution for explainability that uses the techniques with the highest chance of regulatory success. Contact us for a free demo.

Image of a ship on the ocean of regulatoy uncertainty.

Mentoring along the entire Regulatory pathway 

You have developed fantastic machine learning software, but have no idea of how to get it to market? We'll help you navigate the entire regulatory landscape, with vast experience in the intricacies of AI-specific regulations.

Image of co-founder and director Prof. Dr. Oliver Haase.

Free Micro Consulting

Unsure where to start, or if any of this affects you at all? Or got a specific question regarding your ML validation? Book a free micro consulting with co-founder and director Prof. Dr. Oliver Haase.