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Learning Objectives  
Learning Objectives After the seminar, you will:  be familiar with the regulatory basis of the relevant regulations, directives, laws, and standards (especially IEC 62304 and IEC 82304) and…  
Target Group   
Target Group  This seminar is designed for people who:  are new to the world of medical devices, especially software.  already have experience in medical informatics and documentation…  
Requirements for Participation  
Requirements for Participation Participants can easily follow this seminar, even without any special prior 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.…  
Get to know your trainer  
Medical IT engineer Claudia Schmitt supports Johner Institute customers in standards-compliant software development (IEC 62304), risk management (ISO 14971), and the establishment of management…  
Learning Content  
Learning Content The seminar covers the following topics: Regulatory requirements: 21 CFR Part 803 and 806 FDA definitions for reportable events and recalls FDA reporting deadlines and recall…  
Learning Objectives  
Learning Objectives After the seminar, you will:  be familiar with the legal basis and guidance documents of the FDA. be able to reliably identify and evaluate reportable events. be proficient…  
Target Group  
Target Group This seminar is designed for: Process owners and executives in the area of vigilance/QM PRRC (Person Responsible for Regulatory Compliance) Regulatory affairs managers with FDA…  
Results 191 until 200 out of 1499
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