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PSUR in EU MDR : Signal Detection Process & Challenges

PSUR in EU MDR SIGNAL DETECTION process and challenges

Signal detection and risk management are new to medical devices. As PSUR reports for high-risk devices will be needing Signal Detection, manufacturers need to gear their processes Though the processes and methods are well established in Bio-Pharma, some of the areas that worked for those products may not work or applicable to Devices.

Topics covered in this Comprehensive Guide include:

  • Signal Management Process
  • Methods of Signal Detection
  • Qualitative Method

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