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Get to know your trainers  
Dirk Bethäußer has worked in quality management and approval at various medical device manufacturers for over 20 years. He has established, maintained, and continuously developed QM systems. He is…  
Learning Content  
Learning Content The seminar covers the following topics:  Communication and transaction analysis Fundamentals of internal audits, audit types, audit principles, audit criteria, audit…  
Learning Objectives  
Learning Objectives After the seminar, you will be able to:  plan, conduct, and follow up on risk-based audits.  evaluate conformity and non-conformity (using ISO 13485 as an…  
Target Group  
Target Group This seminar is designed for individuals who want to conduct audits themselves (supplier audits, internal audits), e.g., quality managers or process owners from specialist departments.  
Requirements for Participation  
Requirements for Participation Participants can easily follow this seminar even without any special prior knowledge. A general understanding of standards and knowledge of ISO 13485 is…  
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…  
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…  
Get to know your trainer  
Margret Seidenfaden studied medical technology and business administration and has several years of experience in interna­tional medical device approval. After working for medical device…  
Learning Content  
Learning Content The seminar covers the following topics:  Basics: What is a 510(k)  Selecting a suitable predicate device  Determining points for the substantial equivalence…  
Results 1361 until 1370 out of 1499
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