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Target Group  
Target Group This seminar is designed for:  Clinical Evaluators  Medical Writers  Clinical Affairs Managers  Regulatory Affairs Managers  
Learning Objectives      
Learning Objectives     After the seminar, you will:  be familiar with the relevant regulations and MDCG documents and able to apply the content in practice.  be able to create a…  
Learning Content  
Learning Content The seminar covers the following topics:  Regulatory basis  Conducting the clinical evaluation in accordance with MDR  Preparing the clinical evaluation…  
Get to know your trainer  
Dr. Bernhard Gerstenecker has a PhD in microbiology and has spent his entire professional life in the medical device industry dealing with all aspects of IVD systems. For around 25 years, he…  
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…  
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 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…  
Requirements for Participation  
Requirements for Participation Knowledge of the regulatory requirements of the MDR and IVDR is helpful. However, participants can follow this seminar well even without detailed prior knowledge, as a…  
Target Group  
Target Group This seminar is designed for individuals who, for example, perform one or more of the following roles: Former Safety Officer for Medical Devices    Quality Management…  
Learning Objectives   
Learning Objectives  After the seminar, you will know:  the detailed tasks of the PRRC   the requirements and qualification profile of a PRRC   the organizational interfaces to…  
Results 1391 until 1400 out of 1458
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