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Requirements for Participation  
Requirements for Participation Participants can easily follow this seminar, even without any special prior knowledge. Understanding your own medical devices is helpful.  
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, daily from 9:00 am to 5:00 pm during the specified period. There will be a one-hour lunch break every day and short…  
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 trainers  
Sven Wittorf has been part of the Johner Institute since 2006, starting as a consultant for software development processes. He is passionate about how regulatory requirements can be mapped into…  
Get to know your trainers  
Matthias Hölzer-Klüpfel studied physics at the University of Würzburg. He has been a developer, consultant, and project manager since 2002 and has carried out numerous medical technology projects for…  
Get to know your trainers  
Urs Müller works as a consultant at the Swiss Johner office and supports customers and projects in product development and the development of production equipment for medical technology, focusing on…  
Learning Content  
Learning Content The seminar covers the following topics:  Definition of terms  Regulatory requirements  CSV procedure  CSV validation assessment  CSV and risk…  
Learning Objectives  
Learning Objectives After the seminar, you will be able to:    correctly assign and apply the definitions and terms related to the validation of computerized systems and the regulatory…  
Target Group  
Target Group This seminar is designed for individuals who  are required to validate computerized systems in medical technology companies.  are required to review validation…  
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