Hands-on training Artificial Intelligence (AI) in Medical Devices

Artificial intelligence (AI) based products with a medical purpose are subject to Regulations 2017/745 (MDR) or 2017/746 (IVDR) in the EU and the Medical Devices Act (MPDG) in Germany. The future EU Artificial Intelligence Act (AIA) will also bring even higher barriers to market access. Furthermore, many AI-specific standards and guidelines are currently being published (e.g. by the IG-NB Interest Group of Notified Bodies for Medical Devices in Germany) and best practice methods for the development of AI models are constantly being updated.

For the time being, the challenge for the manufacturer is to implement the development and evaluation of the AI model as processes in its quality management system in accordance with the aforementioned requirements. In order to take AI-specific particularities into account, he must also adapt other regulatory processes, for example for the software life cycle and risk management as well as for clinical evaluation and usability.

In our hands-on training, we will first familiarise ourselves with a fictitious example company and its AI-based medical device software. We look at the training and testing of a simple artificial neural network as an AI model in the statistical programming language „R“, insofar as this is necessary for the regulatory treatment of the product. For this purpose, we use a real and publicly available AI model with a medical purpose as an example. We apply various templates to this step-by-step and develop solutions together, which you can then later transfer to your product.

Target group

The event is aimed at employees in medical technology companies who deal with the regulatory compliance of AI-based medical devices. No (programming) technical knowledge is required for the AI model demonstrated here. It merely serves to learn the procedure on a real product.

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