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Requirements for Participation  
Requirements for Participation Participants can easily follow this seminar even without any special prior knowledge. Feel free to bring your process descriptions to the seminar so that we can check…  
Learning Content  
Learning Content The seminar covers the following topics: Legal framework and requirements of the FDA  Procedure of FDA inspections  Preparation for FDA inspections  Best…  
Learning Objectives  
Learning Objectives After the seminar you will be able to:    prepare for an FDA inspection, in particular,  identify gaps,  prepare the documentation, and  brief…  
Get to know your trainers  
After studying biomedical engineering and completing further training as a regulatory affairs manager, Katharina Keutgen spent many years working in development and regulatory affairs for…  
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…  
Results 1471 until 1480 out of 1502
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