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How is the course conducted?  
How is the course conducted? The course takes place either in person or online over five days (spread over two weeks), daily from 9:00 am to 5:00 pm during the specified period. There will be a…  
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…  
Get to know your trainers  
Medical IT engineer Claudia Schmitt supports Johner Institute customers in standards-compliant software development (IEC 62304), risk management (ISO 14971), and establishing management systems (ISO…  
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 will cover the following topics: Legal framework: AI Act, MDR, and ISO 42001 in interaction ISO 42001 basics: structure, concept, and AI-specific requirements…  
Learning Objectives   
Learning Objectives  After the seminar, you will: understand the requirements of ISO 42001 and their relevance for your company. be able to identify overlaps and conflicts between ISO 13485, ISO…  
Target Group  
Target Group This seminar is aimed at manufacturers of medical and in vitro diagnostic medical devices, in particular: Small and young companies: Medical device manufacturers, including DiGA…  
Requirements for Participation  
Requirements for Participation Participants can easily follow this seminar even without any special prior knowledge. Understanding your own medical devices and QM system is helpful.  
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