In the e-learning course "EU AI Act", you learn step by step how to understand the requirements of the EU AI Act. With templates and concrete instructions, you adapt your AI-based medical devices and in-vitro diagnostics (IVD) to the requirements of the regulation.
The course is divided into seven consecutive sprints, from introduction to completion. In between are regulatory basics, gap analysis, planning, roles and competencies, and the implementation itself. You work through the sprints independently and at your own pace. Your progress is continuously recorded. This way, you can continue at any point where you paused.
Each sprint includes a template library with checklists and templates. These include requirements for training data, the description of training data and data preparation, as well as the specification of model requirements. A description of the training process and a model description are also included. According to the provider, these materials are regularly updated and are permanently available to you.
You learn whether your medical devices or IVD fall under the AI Act and how to orient yourself within the AI Act. The course shows you which additional requirements you must fulfill as a manufacturer. You create a gap analysis and an implementation plan with tasks, time and effort estimates. You expand your technical documentation, such as intended purpose and risk management file. Your QM system, roles and competencies, training, and communication with supervisory authorities are also covered.
The course is aimed at manufacturers of AI-based medical devices and IVD, especially those with a QM system according to ISO 13485. It addresses those responsible from Regulatory Affairs, Quality Management, Development and Product Management, Data Science, as well as IT Security and Data Protection.
You receive access to the e-learning platform as well as a task booklet. It helps you with implementation as well as with planning and executing the measures. After successful completion, a certificate as proof of your AI Act expertise is available for download. If you have technical problems or questions, the provider's e-learning team will help you via email.
