In the "EU AI Act" e-learning course, you'll learn step by step how to understand the requirements of the EU AI Act. Using templates and concrete instructions, you will 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 foundations, gap analysis, planning, roles and competences, and the implementation itself. You will work through the sprints independently and at your own pace. Your progress is recorded continuously. This allows you to 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 updated regularly and are available to you permanently.
You learn whether your medical devices or IVDs fall under the AI Act and how to navigate 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 competences, training, and communication with supervisory authorities are also covered.
The course is aimed at manufacturers of AI-based medical devices and IVDs, 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 get access to the e-learning platform and a task booklet. It helps you with the implementation as well as with the planning and execution of measures. Upon 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 by email.
