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Get to know your trainers  
After completing her studies, Claudia Volk gained several years of experience as a quality and regulatory affairs manager in a regulated environment, initially in food production and later as a…  
Learning Content  
Learning Content The seminar covers the following topics: Historic background   Scope of the QMSR   Overview of the structure of the QMSR   Understanding and implementing…  
Learning Objectives  
Learning Objectives After the seminar, you will know:    the scope of the QMSR.   the contents of the QMSR (Note: Since ISO 13485 makes up a large part of the QMSR, the discussion of…  
Target Group   
Target Group  This seminar is designed for people who have/will take on one or more of the following roles:    Quality Managers    Management Representatives (“QMR”)    Regulatory…  
Requirements for Participation  
Requirements for Participation The seminar is aimed at people with little or no knowledge of ISO 13485. Therefore, participants can easily follow this seminar without any special previous knowledge.  
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:  Definition of a management system according to ISO 15189, including required documents  New elements compared to the previous…  
Learning Objectives  
Learning Objectives After the seminar, you will: be confident going into new or re-accreditation.  understand how 15189:2022 interacts with other regulations and standards.  know what…  
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