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Learning Objectives  
Learning Objectives After the seminar, you will be able to:    determine the requirements for the device.  distinguish between the terms “basic safety” and “essential performance” and…  
Target Group  
Target Group This seminar is designed for:  Hardware and Embedded Developers  Architects and System Engineers  Project Managers  Risk Managers  All persons entrusted…  
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.   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 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 an overview of the contents of the QMSR (Note: Since ISO 13485 makes up a large part of the QMSR, the…  
Results 1321 until 1330 out of 1499
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