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Get to know your trainer  
Dr. Juliane Havlicek is a biotechnologist with many years of industry experience with IVD medical device manufacturers. As team leader, she developed various in vitro diagnostic tests (IVD). She…  
Learning Content  
Learning Content The seminar covers the following topics:  Regulatory requirements of the IVDR for performance evaluation  Concept of clinical evidence and clinical benefit of an…  
Learning Objectives   
Learning Objectives  After the seminar, you will be able to:  derive and justify the performance evaluation strategy specific to your device.  focus on the scope of the performance…  
Target Group  
Target Group This seminar is designed for:  Persons responsible for performance evaluation  Laboratory staff  Development and laboratory heads  Development department staff…  
Requirements for Participation  
Requirements for Participation After registering, you will receive a confirmation email containing the meeting link, the time, and information about the participants.   An invoice will be sent…  
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   
Ulrich Hafen is our specialist for regulatory requirements for medical laboratories. He assists manufacturers of in-house IVD medical devices in meeting IVDR requirements and provides support with…  
Learning Content  
Learning Content The seminar covers the following topics:  Differences between in-house IVD medical devices and CE IVD tests  Significance and impact of the IVDR requirements specific to…  
Learning Objectives  
Learning Objectives After the seminar, you will: be able to identify in-house IVD medical devices and distinguish them from CE-IVD medical devices, general laboratory supplies, and devices for…  
Results 1131 until 1140 out of 1352
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