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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…  
Learning Content  
Learning Content The seminar covers the following topics: Technical expertise, legal basis MDR and IVDR (Article 15), Guidance MDCG 2019-7    Individual tasks of the Person Responsible for…  
Get to know your trainer  
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…  
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 Participants should be familiar with the general requirements and structure of the MDR and IVDR. We also recommend our Compact Seminar Medical Device Regulation…  
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