Pooling expertise with AI/ML software as a medical device (SaMD) in compliance with MDR regulations and software innovation

Our team's expertise in AI development, data management, labeling, and regulatory affairs ensures that your project meets all necessary requirements for market readiness, such as MDR.

Compliance by Design
We integrate the right inputs and regulatory standards for data, labeling, development, and validation right from the start, reducing time to market and unnecessary costs. Quality requirements and data population selection are increasingly becoming the focus of Notified Bodies. 
Our risk-based approach to data selection, combined with our documented labeling processes, ensures that the right data is selected with the highest quality. An AI model is only as good as the data selected for training!

With our experienced team and versatile technology, we cover various applications, including classification for diagnosis, clustering for data analysis, segmentation for CAD model creation from image data (CT, MR, DVT), and generative AI with unlimited possibilities.

 

We combine expertise in labeling, AI development, and regulatory affairs to bring your product to market safely and quickly.


Interested? Please, get in touch!