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Get to know your trainer  
As a human biologist, Dr. Manuela Reinhold advises on regulatory issues and approval strategies for medical devices at the Johner Institute. She previously worked as a scientist, then in…  
Learning Content  
Learning Content The seminar covers the following topics: Regulatory framework for medical laboratories (ISO 15189, ISO 22367, IVDR, Rili-BÄK) Definitions and terms according to ISO 22367 Risk…  
Learning Objectives  
Learning Objectives After the seminar, you will be able to: define comprehensible risk acceptance criteria systematically identify hazards and estimate risks define appropriate measures for risk…  
Target Group  
Target Group This seminar is designed for: Laboratory heads Scientific staff Employees in the field of quality management Risk managers Medical staff Those in charge of the development of…  
Requirements for Participation  
Requirements for Participation Participants can easily follow this seminar even without any special prior knowledge. An understanding of one's own examination procedures, in particular one's own…  
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 trainer  
Dr. Sophie Bartsch is a biologist and worked as a research assistant in an accredited diagnostic laboratory for three years after completing her doctorate. In addition to routine diagnostics, she was…  
Learning Content  
Learning Content The seminar covers the following topics:  Qualification and classification of medical software  Regulatory system  Requirements of the MDR and IEC 62304 …  
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