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Get to know your trainers  
Margret Seidenfaden studied medical technology and business administration and has several years of experience in interna­tional medical device approval. After working for medical device…  
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…  
What happens if questions or problems arise?  
What happens if questions or problems arise? If you experience technical problems while participating or have any other questions, you can contact our support team anytime, even at short notice. The…  
Learning Content  
Learning Content The seminar covers the following topics: Background and basic regulatory requirements  Medical device classification  General requirements for marketing in the…  
Learning Objectives      
Learning Objectives     In this seminar, you will learn about the basic requirements that the FDA imposes on the marketing of medical devices, which you and your company must know, understand, and…  
Target Group   
Target Group  This seminar is aimed at individuals involved in marketing medical devices in the US who would like to gain an overview of the FDA requirements. It is also aimed at individuals entering…  
Requirements for Participation  
Requirements for Participation The seminar is also suitable for beginners and those who "only" want to gain an overview of the US FDA requirements. However, depending on the participants'…  
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…  
Get to know your trainer  
As an engineer for biomedical technology, Christian Rosenzweig was responsible for basic and software development for complex active medical devices for many years. As the person responsible for…  
Requirements for Participation  
Requirements for Participation Participants can follow this seminar well even without any special prior knowledge. Understanding their own medical devices is helpful.   
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