Your starter kit for compliance with the EU AI Act

The essential quick start for IVD and medical device manufacturers

The AI Act Starter Kit gives you:

• Clarity through a detailed overview of all the necessary documents that you need to create or amend for your QM system.
• Efficient planning and less stress because you know what the AI Act specifically requires of you as an IVD or medical device manufacturer and which tasks need to be completed.  
• Legal certainty by avoiding costly rework and legal problems through early and correct implementation of the legal requirements.

The AI Act Starter Kit contains:

• Document list: A comprehensive list of all QM documents that need to be newly created or amended and a brief description of the content or amendments.
• Mindmap: A visual representation of the chapter structure of the EU AI Act as a PDF and in XMind format for a quick overview.   
• Additional resources: Links to further information and relevant legal texts.