Add an eventREGULATOR: Comprehending and Complying to the New EU Guideline on the Qualification and Classification of Standalone Software in
A session at 2nd Annual Software Design for Medical Devices Europe
- Defining both “software” and the changes in the guideline
- Demonstrating the new qualification criteria and decision trees
- Discussing general health care IT systems at the borderline of medical device software
- Learning from examples and frequently asked questions
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2nd Annual Software Design for Medical Devices Europe
31st January to 2nd February 2012