E-Learning Course "EU AI Act"

Happy People listening to a seminar
Step by step and at your own pace to AI Act confor­mity – with our practice-oriented e-learning course
Happy People listening to a seminar
Step by step and at your own pace to AI Act confor­mity – with our practice-oriented e-learning course

In this practical e-learning course, we provide step-by-step support to help you understand the require­ments of the EU AI Act. 

With special templates and concrete instruc­tions, we help you adapt your AI-based medical devices and in vitro diagnostic medical devices (IVD) to ​​​​​​​the require­ments of the EU AI Act and successfully implement the specifications. 

The course goes beyond mere understanding and offers you concrete assistance in complying with the requirements of the EU AI Act. 

Book Now: E-Learning Course "EU AI Act"

Price incl. 3 licenses 3950,00 € plus VAT

4700,50 € (including VAT)
 

Send us an e-mail to [email protected]​​​​​​​ to book the e-learning course.

Master the challenges of the EU AI Act on your own, with flexibility and without stress, using our e-learning format

Seven consecutive sprints systema­tically guide you to AI Act conformity. ​​​​​​​The course serves as a practical guide for implementation on your own. ​​​​​​​You learn at your own pace and can inte­grate the course into your daily work routine. We show you how to expand your existing documen­tation and QM structure while avoiding potential redundancies. 

100% of participants recommend this seminar!

We have not yet received any written feedback on this course.

Direct results instead of theoretical concepts: Expand your TD and QMS while you do the course

We provide you with a suitable library contai­ning checklists and templates, which are regularly updated and expanded. This allows you to apply your newly acquired knowledge directly after each sprint and keep your techni­cal documentation and quality manage­ment system compliant at all times, thanks to permanent access to all materials. 

Benefit from the expertise of the market leader in regula­tory affairs through self-study, without paying the usual consulting fees

In this course, we pass on our knowledge and experience of the AI Act directly to you, making you independent of guidance from external consultants. Our struc­tured learning program ensures that you reach ​​​​​​​your milestones on time and avoid typical pitfalls. This way, you can complete your next audits and assessments with maximum safety. 

Certified Qualification

Document your AI Act expertise with a recognized certificate upon completing the e-learning course successfully.

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Learning Content

The e-learning course covers the following topics, which build on each other: 

  • Sprint 1: Introduction, Awareness, and Motivation   
  • Sprint 2: Regulatory Basics   
  • Sprint 3: Gap Analysis   
  • Sprint 4: Implementation Planning   
  • Sprint 5: Roles and Competences   
  • Sprint 6: Implementation 
  • Sprint 7: Review, Retrospective, and Completion

In the accompanying library, you will find templates for the following documents: 

  • Training Data Requirements 
  • Training Data Description 
  • Model Requirements Specification 
  • Data Preparation Description 
  • Training Process Description 
  • Model Description 
Learning Objectives

In the e-learning course, you will learn:

  • how to determine whether your medical devices or IVDs fall under the AI Act. 
  • how to navigate the AI Act and recognize its relevance for your devices. 
  • what additional requirements you must comply with as a manufacturer. 
  • how to perform a gap analysis to identify gaps. 
  • how to create an implementation plan that defines tasks, time and effort estimates, and responsibilities. 
  • how the technical documentation, including the intended purpose and risk management file, should be expanded. 
  • how to adapt your QM system, determine roles and competences, plan training, and communicate with authorities. 
Target Group 

This course is specifically designed to meet the needs of manufacturers of AI-based medical devices and IVDs. The focus is on manufacturers with a QM system in accordance with ISO 13485. 

Typical course participants are managers from the following areas:

  • Regulatory Affairs 
  • Quality Management 
  • Development and Product Management 
  • Data Science 
  • IT Security and Data Protection 
How can I book the e-learning course?

This special e-learning course is available on request.

Email us at [email protected] to request a quote directly.

Alternatively, you can request an initial meeting to learn more about the e-learning course and get answers to your questions.

How do I conduct the e-learning course?

You will receive access to our e-learning platform, where you can complete the course on your own and at your own pace.  

In addition to the course, you will receive a workbook that will help you with the course itself and with planning and implementing measures on the path to AI Act conformity.  

Your progress will be tracked continuously, and you can pick up where you left off anytime.

Upon successfully completing the e-learning course, you will receive a certificate as proof of your newly acquired expertise, which you can download.

What happens if questions or problems arise?

If you encounter any technical problems or have any other questions, please contact our e-learning team anytime by emailing [email protected]​​​​​​​.

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