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Learning Objectives  
Learning Objectives After the seminar, you will be able to:  fill out eSTAR correctly.  identify and justify a predicate device.  write an SE discussion.  distinguish…  
Target Group  
Target Group This seminar is designed for:  Regulatory affairs employees  Employees responsible for preparing and submitting (parts of) a 510(k) submission  
Requirements for Participation  
Requirements for Participation Basic knowledge of the FDA's general requirements is recommended, e.g., through our "FDA Compact Seminar," but is not mandatory.  Basic English skills are…  
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  
After studying health management, Dirk Bethäußer worked for many years at various medical device manufacturers, where he was responsible for setting up and expanding an entire QM department as…  
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 following topics are covered in the seminar: Basics Definition of quality, objectives of quality management  Role of ISO 13485, also in the context of MDR …  
Results 1371 until 1380 out of 1499
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