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Target Group  
Target Group This seminar is aimed at manufacturers of medical and in vitro diagnostic medical devices, in particular: Small and young companies: Medical device manufacturers, including DiGA…  
Requirements for Participation  
Requirements for Participation Participants can easily follow this seminar even without any special prior knowledge. Understanding your own medical devices and QM system 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 sent…  
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.…  
Get to know your trainers  
Andreas Kalchschmid-Lehmann is an expert in QM and in vitro diagnostic medical devices with more than 17 years of practical experience. He is the author of the book “ISO 13485 – Chance statt Hürde”…  
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 course covers the following topics: Becoming familiar with and interpreting the requirements of EN ISO 13485 Definition of relevant terms in EN ISO 19011:2018 Audit…  
Learning Objectives  
Learning Objectives After the course, you will be able to:  correctly interpret and apply ISO 13485 in detail. plan, conduct, and follow up on audits in a risk-based manner. evaluate conformity…  
Target Group  
Target Group This course is designed for individuals who plan and conduct audits of quality management systems according to ISO 13485 and wish to obtain a corresponding, recognized…  
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