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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…  
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: Regulatory framework in Europe with embedding of risk management Definitions according to ISO 14971 (with practical exercise) Risk…  
Learning Objectives   
Learning Objectives  After the seminar, you will be able to:  define comprehensible risk acceptance criteria.  systematically identify hazards and assess risks.  define suitable measures for…  
Target Group   
Target Group  This seminar is designed for people who will (in the future) take on one or more of the following roles:  Risk Manager  Quality and Regulatory Affairs Manager  Product Manager and…  
Study Design  
Study Design Our experts help you determine the appropriate study design for your analytical and clinical performance studies.   
Experimental Design  
Experimental Design We help you set up the experimen­tal design for the requi­red analytical perfor­mance studies and document these in test plans that comply with regulatory requirements.    
Selection of Suitable CROs    
Selection of Suitable CROs   We can help you select a suitable contract research organization (CRO) that specializes in IVD medical devices and is familiar with the spe­ci­fic requirements.   
Submission to Authorities    
Submission to Authorities   We can help you create the clinical performance study plan (CPSP), which you can submit directly and without problems.  
Results 1461 until 1470 out of 1478
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