GenAI-Med

Regulatory requirements in the medical technology industry will continue to increase in the coming years. The implementation of the European Medical Device Regulation (MDR) in particular calls for pragmatic, simple, and sustainable solutions to mitigate challenges in the certification of existing and new products as effectively as possible.

The use of generative artificial intelligence makes it possible to implement high-quality and cost-effective approval processes. For many medical technology companies, however, integrating digital technologies into existing processes is difficult to envision. The goal of GenAI-Med is to use concrete examples to demonstrate the benefits of using Generative AI and the improvements and cost savings that are possible compared to conventional processes.

Workshops are being held with companies in the medical technology sector to identify promising ideas for AI applications. Proven methods, such as the AI Canvas, are used in these workshops. The ideas gathered are described as use cases and evaluated in terms of feasibility and potential benefits.

The result is a demonstrator that illustrates the potential of using generative AI in the regulatory approval process for medical device companies using concrete examples. The demonstrator was tested and evaluated with a user group from the medical device industry. The findings were published in the form of a guide containing recommendations for action.

Companies that would like to receive further information about the project or are interested in participating are welcome to contact jens.drawehn@iao.fraunhofer.de 

In addition to medical technology companies, certification service providers, notified bodies, and AI service providers are also welcome to participate.