Note: The blog is excluded from the website search. If you want to search for something in the blog, you must use the blog's search function. Please contact us if you cannot find the information you are looking for using either the navigation or the search function. We will be happy to help you.

Results

For the search term: "..."

1352 Search result(s):
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 trainer  
Margret Seidenfaden studied medical technology and business administration and has several years of experience in interna­tional medical device approval. After working for medical device…  
Learning Content  
Learning Content The seminar covers the following topics:  Basics: What is a 510(k)  Selecting a suitable predicate device  Determining points for the substantial equivalence…  
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…  
Results 1221 until 1230 out of 1352
X

Privacy settings

We use cookies on our websites. Some of them are essential, while others help us to improve this website and your experience.