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REGULATOR: 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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