Meetings/Workshops on Regulation in Medicine and Pharmacology in Switzerland
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Course — How to apply ISO 62304 standard in a medical software development project?
04 Mar 2019 - 05 Mar 2019 • Zurich, Switzerland, Switzerland
This course will give an introduction how to develop medical software under the requirements of the ISO 62304 and how to apply these in a medical software development project and how a smart application during the medical software development and in the post market process is possible. Further the risk management of medical software development. In the European Union is the application of the ISO 62304 for medical software mandatory and part of the essential requirements of the medical device regulation. In the technical documentation is required to approve the development process and the life cycle of medical software according ISO 62304.
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ISO 62304 standard for medical software development, medical software development project, post market process, medical software risk management process, quality management system, ISO 13485, EU MDR, medical software maintenance process
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Last updated: 23 January 2019