This seminar provides you with comprehensive knowledge of risk management and the competence to coordinate all your company's risk management activities and create compliant risk management files for your medical devices.
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Among other things, you will learn how to define comprehensible risk acceptance criteria, systematically identify hazards, evaluate risks, and define suitable measures for risk control. Our expert will show you how to compile all this information quickly and compactly in your risk management file and check it for compliance.
In contrast to a purely theoretical lecture, our trainer uses practical exercises and sample documents to help you transfer what you have learned directly into your everyday work and onto your devices. Instead of clinging to rigid plans and examples of little relevance, he explains the material using real devices and addresses your specific case.
Unlike typical inspectors, our trainer does not just point out mistakes but uses his own daily work to teach you the best practices for creating precise and compliant risk management files. In this seminar, you will receive concrete guidance and precise answers to your questions so that you can pass your future audits and reviews successfully.
You can find the exact learning content, further information on the seminar, and the schedule in the agenda:
Note: There is a voluntary online exam at the end of the seminar (duration: approx. 20 min). By passing this exam, you will receive a certificate proving your newly acquired knowledge and skills in addition to your attendance confirmation.