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Course Content  
Course Content In this seminar, you will learn what requirements the EU AI Act actually imposes on users of AI systems and how to implement them in a practical manner within regulated environments: …  
In-house Production of IVD Medical Devices  
Achieve IVDR compliance for your health institution (e.g., your medical laboratory) and your in-house IVD medical devices in the shortest possible time.  
Assisted Self-Service  
With our self-service solutions, we aim to support startups and manufacturers with limited budgets in overcoming regulatory hurdles on their own.  
E-Learning  
With our e-learning offerings, you can educate and train yourself individually and master the approval of your medical and IVD medical devices completely on your own.  
Auditgarant Book Demo  
The Auditgarant is the fastest and most cost-effective way to successfully market your medical or IVD medical device.  
Auditgarant  
The Auditgarant is the efficient way to successfully bring your medical or IVD medical device to market.  
Day 1  
Day 1 Tuesday | 9.00 am to 12.30 pm | FDA requirements (full day, including lunch break*)  
Day 2  
Day 2 Thursday | 9 am to 1 pm | 510(k): part I  
Day 3  
Day 3 Tuesday (next week) | 9 am to 1 pm | 510(k): part II  
Day 4  
Day 4 Thursday (following week) | 9.00 am to approx. 3.45 pm | FDA inspection and vigilance requirements  
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