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

The first challenge for manufacturers is to implement the development and evaluation of the AI model as processes in their quality management system in accordance with the relevant requirements. Other regulatory processes, such as software lifecycle and risk management, clinical evaluation, and usability, also need to be adapted to take account of AI-specific features.

Hands-on Training

In our hands-on training, we first get to know a fictitious company and its AI-based medical device software. We consider the training and testing of a simple artificial neural network as an AI model, as far this is required for the regulatory handling of the product. Using this real and publicly available AI model with a medical purpose as an example we apply various AIA- and MDR-ready regulatory templates (in English) step by step, which can later be transferred to your product.

Participants of this hands-on training will receive all presented documents as PDF and also a list of requirements for medical devices as high-risk AI systems according to the provisions of the AIA.

As a special bonus, all participants of this event will receive a list of the requirements for medical devices as high-risk AI systems in accordance with the provisions of the Artificial Intelligence Act in PDF format.

Target Group

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