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Learning Content  
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   …  
Learning Objectives  
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…  
Target Group   
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…  
Get to Know your Trainers   
M.Eng. Anja Bentz completed a dual degree program in electrical engineering after finishing her training as a biological-technical assistant, followed by a master’s degree in medical technology with…  
Learning Content  
Learning Content In this seminar, you will learn how to properly classify, develop, and document your AI-based medical devices and in vitro diagnostic devices in accordance with regulatory…  
Learning Objectives  
Learning Objectives By attending this seminar, participants will achieve the following objectives: Participants will be able to identify which requirements for AI-based medical devices and IVDs…  
Target Group  
Target Group This seminar is intended for employees of medical device and IVD manufacturers who develop, document, or conduct regulatory assessments of AI-based products. These individuals typically…  
Requirements for Participation  
Requirements for Participation Sie profitieren optimal von diesem Seminar, wenn Sie folgende Voraussetzungen mitbringen:   Kenntnisse von MDR und IVDR  Grundverständnis des…  
What happens after registration?  
What happens after registration? After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.   An invoice will be…  
How is the seminar conducted?   
How is the seminar conducted?  The seminar takes place either in person or online.   Our online/remote seminars and workshops are conducted via the video conferencing tool MS Teams. We…  
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