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Learning Objectives  
Learning Objectives After the seminar, you will know:    the scope of the QMSR an overview of the contents of the QMSR (Note: Since ISO 13485 makes up a large part of the QMSR, the…  
Target Group   
Target Group  This seminar is designed for people who have/will take on one or more of the following roles:  US medical device manufacturers with and without plans to expand into Europe QM…  
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…  
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 e-learning course covers the following topics, which build on each other:  Sprint 1: Introduction, Awareness, and Motivation    Sprint 2: Regulatory Basics   …  
Learning Objectives  
Learning Objectives In the e-learning course, you will learn: how to determine whether your medical devices or IVDs fall under the AI Act.  how to navigate the AI Act and recognize its…  
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